Ventyx Biosciences Inc (VTYX) 2024 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon, ladies and gentlemen, and welcome to the Ventyx Biosciences first quarter 2024 earnings conference call. (Operator Instructions) As a reminder, this conference call is being recorded.

    女士們、先生們,下午好,歡迎參加 Ventyx Biosciences 2024 年第一季財報電話會議。(操作員說明)謹此提醒,本次電話會議正在錄音。

  • I would now like to turn the call over to Dr. Martin Auster, Ventyx Chief Financial Officer. Please begin.

    我現在想將電話轉給 Ventyx 財務長 Martin Auster 博士。請開始。

  • Martin Auster - Chief Financial Officer

    Martin Auster - Chief Financial Officer

  • Thank you, operator, and good afternoon to everyone joining us today. Welcome to Ventyx Biosciences' conference call webcast. We will be discussing our first quarter 2024 financial results and providing a corporate update.

    謝謝您,接線員,今天加入我們的大家下午好。歡迎收聽 Ventyx Biosciences 的電話會議網路廣播。我們將討論 2024 年第一季的財務表現並提供公司最新情況。

  • Before we begin, I would like to remind everyone that today's presentations will include forward-looking statements. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected.

    在開始之前,我想提醒大家,今天的演示將包含前瞻性陳述。這些陳述存在風險和不確定性,可能導致實際結果與預測有重大差異。

  • Description of these risks can be found in our Form 10-Q for the quarter ended March 31, 2024, which was just recently filed this afternoon. Any forward-looking statements are made only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call.

    這些風險的描述可以在我們今天下午剛提交的截至 2024 年 3 月 31 日的季度的 10-Q 表格中找到。任何前瞻性陳述僅截至今天為止,我們不承擔更新今天電話會議上所做的任何前瞻性陳述的義務。

  • And with that, I'll hand the call over now to Dr. Raju Mohan, Ventyx's Founder and CEO. Raju you please go ahead?

    現在,我將把電話轉交給 Ventyx 創辦人兼執行長 Raju Mohan 博士。拉朱,請繼續吧?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah. Thanks, Marty, and thank you, everyone, for joining us for our first quarter 2024 earnings call and corporate update. As we recently provided a full pipeline of strategic update at our March Investor Day. I will be brief with my remarks today. Let me take a few minutes to provide some high-level comments on the status of our pipeline programs, and then I'll hand the call back to Marty to review our first quarter financial results.

    是的。謝謝 Marty,也謝謝大家參加我們的 2024 年第一季財報電話會議和公司最新動態。正如我們最近在三月投資者日提供的完整策略更新。我今天的發言將很簡短。讓我花幾分鐘時間對我們的管道計劃的狀況提供一些高級評論,然後我會將電話轉給馬蒂,以審查我們第一季的財務業績。

  • We'll then open the floor to Q&A, where I'll be again joined by Marty and also with John Nuss, our Chief Scientific Officer. So I'll begin with our portfolio of potential best in class NLRP3 inhibitors.

    然後我們將開始問答環節,馬蒂和我們的首席科學官約翰·努斯將再次加入我的問答環節。因此,我將從我們潛在的同類最佳 NLRP3 抑制劑產品組合開始。

  • In March, we announced positive top line results from a Phase 1 single and multiple ascending dose trial of VTX3232, our novel CNS-Penetrant and NLRP3 inhibitor in adult healthy volunteers. As you may remember, repeat VTX3232 doses as low as 3 milligrams once daily achieved steady-state IL-1 beta IC50 coverage in both plasma and CSF and repeat doses of 20 milligrams all the way up to 40 milligrams QD well exceeded IL-1 beta IC90 coverage in both plasma and CSF.

    今年 3 月,我們宣布了 VTX3232(我們的新型 CNS 滲透劑和 NLRP3 抑制劑)在成年健康志願者中進行的 1 期單次和多次遞增劑量試驗的積極頂線結果。您可能還記得,每天重複一次低至3 毫克的VTX3232 劑量即可在血漿和腦脊髓液中實現穩態IL-1 β IC50 覆蓋,而重複劑量從20 毫克一直到每日40 毫克,遠遠超過IL- 1 β血漿和腦脊髓液中的 IC90 覆蓋率。

  • Based on these data and our dose up on a dose projection modeling we estimate that VTX3232 doses as low as 12 milligram once daily may be adequate to achieve IL-1 beta IC90 target coverage in the CSF and in plasma.

    根據這些數據和劑量預測模型的劑量增加,我們估計每日一次低至 12 毫克的 VTX3232 劑量可能足以在 CSF 和血漿中實現 IL-1 beta IC90 目標覆蓋率。

  • We also observed robust dose-dependent pharmacodynamic or PD effects in a whole blood ex vivo, IL-1 beta stimulation assay and VTX3232 also showed excellent tolerability showed an excellent tolerability profile in this Phase one study.

    我們也在離體全血、IL-1 β刺激測定中觀察到了強大的劑量依賴性藥效學或PD 效應,並且VTX3232 也表現出出色的耐受性,在此一期研究中表現出出色的耐受性。

  • We thus believe that these data established VTX3232 as a potential best in class drug candidate for the treatment of neuro inflammatory diseases and conditions. This includes excellent target coverage in plasma and CSF, favorable safety profile and a convenient once daily oral dosing regimen with our tablet formulation. VTX3232 is a Phase 2 ready compound.

    因此,我們相信這些數據使 VTX3232 成為治療神經發炎疾病和病症的潛在最佳候選藥物。這包括血漿和腦脊髓液中出色的目標覆蓋、良好的安全性以及我們的片劑配方方便的每日一次口服給藥方案。VTX3232 是一種已進入第 2 階段的化合物。

  • As we also communicated in March, we plan to rapidly advance VTX3232 in to Phase 2 trials in high-value indications with substantial unmet need, beginning with the Phase 2a trial of VTX3232 in patients with early Parkinson's disease, which we will initiate in the second half of this year.

    正如我們在3 月所傳達的那樣,我們計劃迅速將VTX3232 推進到有大量未滿足需求的高價值適應症的2 期試驗,首先是VTX3232 在早期帕金森氏症患者中的2a 期試驗,我們將在第二年啟動試驗。

  • As we discussed, a growing body of preclinical evidence has implicated NLRP3 mediated inflammation as a key driver of Parkinson's disease pathology by impacting neuronal death and degeneration. We therefore, believe that NLRP3 inhibition represents a promising potentially disease-modifying therapeutic approach in this devastating neurodegenerative condition.

    正如我們所討論的,越來越多的臨床前證據表明 NLRP3 介導的發炎透過影響神經元死亡和變性而成為帕金森氏症病理學的關鍵驅動因素。因此,我們相信 NLRP3 抑制在這種破壞性神經退化性疾病中代表了一種有前途的潛在疾病緩解治療方法。

  • More recently, NLRP3 has also created much buzz and discussion as a potentially important target for obesity and obesity-related metabolic diseases. Much of it due to data published last February, showing central NLRP3 mediated weight loss in obese mice.

    最近,NLRP3 作為肥胖和肥胖相關代謝疾病的潛在重要標靶也引起了廣泛的關注和討論。其中大部分歸因於去年 2 月發布的數據,該數據顯示中樞 NLRP3 介導肥胖小鼠的體重減輕。

  • We have initiated our own studies with VTX3232 and neuroi models of diet-induced obesity similar to the published models we just talked about. In addition to assessing weight loss induced by the VTX3232 and with the GLP-1 aganist semaglutide in a monotherapy study we're also evaluating the VTX3232 in combination with semaglutide. These are exciting studies, and we look forward to providing an update on these studies later in the second quarter.

    我們已經開始使用 VTX3232 和飲食誘發肥胖的神經元模型進行自己的研究,類似於我們剛才談到的已發表的模型。除了在單藥治療研究中評估 VTX3232 和 GLP-1 激動劑索馬魯肽誘導的體重減輕外,我們還在評估 VTX3232 與索馬魯肽聯合用藥。這些都是令人興奮的研究,我們期待在第二季晚些時候提供這些研究的最新資訊。

  • So now moving from mice to humans, we plan to initiate a Phase 2 trial of VTX3232 during the second half of 2024 in obese participants with certain additional cardiovascular risk factors.

    因此,現在從小鼠轉向人類,我們計劃在 2024 年下半年在具有某些額外心血管危險因子的肥胖參與者中啟動 VTX3232 的 2 期試驗。

  • Now moving on to our VTX3232 peripherally restricted NLRP3 inhibitor. In March, we announced positive top-line results from a Phase 2 trial of VTX2735 in patients with cryopin-associated periodic syndromes or CAPS. In this trial, VTX2735 demonstrated efficacy comparable to that observed with IL-1 biologics, the current standard of care.

    現在轉向我們的 VTX3232 外周限制性 NLRP3 抑制劑。今年 3 月,我們宣布了 VTX2735 在冷凍針相關週期性綜合症 (CAPS) 患者中進行的 2 期試驗取得了積極的頂線結果。在這項試驗中,VTX2735 表現出的療效與目前護理標準 IL-1 生物製劑觀察到的療效相當。

  • VTX2735 also demonstrated consistent and robust reductions in inflammatory biomarkers such as hsCRP, high-sensitive CRP, IL-6, serum amyloid A and for fibrinogen. It was also a mean reduction of 85% in the key symptom score for these CAPS patients during the initial treatment period with a very favorable safety profile was all treatment-related adverse events graded as mild.

    VTX2735 也表現出一致且強勁的發炎生物標記物降低作用,例如 hsCRP、高敏 CRP、IL-6、血清澱粉樣蛋白 A 和纖維蛋白原。在初始治療期間,這些 CAPS 患者的關鍵症狀評分平均降低了 85%,所有與治療相關的不良事件均評級為輕度,因此安全性非常良好。

  • These Phase 2 data and CAPS patients is therefore a compelling proof of mechanism for VTX2735 for our peripheral inhibitor and for systemic inhibition of NLRP3-related biomarkers in general, including hsCRP and IL-6.

    因此,這些 2 期數據和 CAPS 患者是 VTX2735 對於我們的周邊抑制劑和 NLRP3 相關生物標記(包括 hsCRP 和 IL-6)的全身抑制機制的有力證明。

  • And as we communicated in March, we plan to evaluate VTX2735 for future development, cardiovascular and potentially other indications with an initial focus on recurrent pericarditis and also in the secondary prevention of major adverse cardiovascular events or MACE. Both recurrent pericarditis, RP and MACE prevention represent indications with large addressable markets and substantial unmet medical need. So we thus plan to update or provide an update on our cardiovascular development plans later in this year.

    正如我們在 3 月所傳達的那樣,我們計劃評估 VTX2735 的未來開發、心血管和潛在其他適應症,最初重點關注復發性心包膜炎以及主要不良心血管事件或 MACE 的二級預防。復發性心包膜炎、RP 和 MACE 預防都代表著龐大的潛在市場和大量未滿足的醫療需求。因此,我們計劃在今年稍後更新或提供我們的心血管發展計劃的更新。

  • Beyond our NLRP3 inhibitor portfolio, the team continues to make progress advancing our IBD assets, including VTX002 our potential best-in-class S1P1 receptor modulator for ulcerative colitis and VTX958 our allosteric inhibitor in Phase 2 development for the treatment of Crohn's disease.

    除了我們的NLRP3 抑制劑產品組合外,該團隊還在繼續推進我們的IBD 資產,包括VTX002(用於治療潰瘍性結腸炎的潛在同類最佳S1P1 受體調節劑)和VTX958(用於治療克羅恩病的2 期開發中的變構抑制劑)。

  • For VTX002, you'll recall that we announced positive Phase 2 data in October of 2023, demonstrating what we believe is a potential best-in-disease profile for an oral agent in ulcerative colitis. This includes a highly differentiated rate of complete endoscopic remission and a potential best-in-class safety profile.

    對於 VTX002,您可能還記得我們在 2023 年 10 月宣布了積極的 2 期數據,證明了我們認為口服藥物治療潰瘍性結腸炎的潛在最佳疾病特徵。這包括高度差異化的內視鏡完全緩解率和潛在的一流安全性。

  • At the March event, we also showed preliminary data from the open-label extension part of the Phase 2 trial, further reinforcing the endoscopic remission data and a differentiated profile. We anticipate that the data from the 52 week long-term extension part of this Phase 2 study will continue to show sustained or perhaps even improved data for endoscopic remission from that observed in the 13 week induction period.

    在三月的活動中,我們也展示了二期試驗開放標籤擴展部分的初步數據,進一步強化了內視鏡緩解數據和差異化概況。我們預計,該 2 期研究的 52 週長期延長部分的數據將繼續顯示與 13 週誘導期觀察到的內視鏡緩解數據相比持續甚至改善的數據。

  • This program is fully Phase 3 ready, and our teams continue to make preparations for a pivotal Phase 3 trial is ongoing. Last month we completed a productive end of Phase 2 meeting with the FDA, and we expect to conduct a scientific advice meeting with the EMA later this quarter.

    該計劃已完全準備好進行第三階段,我們的團隊將繼續為正在進行的關鍵第三階段試驗做準備。上個月,我們與 FDA 完成了富有成效的第二階段會議,我們預計將在本季稍後與 EMA 舉行科學建議會議。

  • We continue to have confidence that our completed Phase two trial may be sufficient to support approval of VTX002, with successful completion of a second pivotal 52-week trial in ulcerative colitis. And as we have previously indicated, efforts are underway to identify a partner or other source of non-dilutive financing to support this pivotal Phase 3 trial.

    我們仍然相信,我們已完成的二期試驗可能足以支持 VTX002 的批准,成功完成第二個為期 52 週的潰瘍性結腸炎關鍵試驗。正如我們之前所指出的,我們正在努力尋找合作夥伴或其他非稀釋性融資來源,以支持這項關鍵的第三階段試驗。

  • Finally, our Phase 2 trial of VTX958, our allosteric TYK2 inhibitor and moderately to severe active Crohn's disease continues to progress. As we've mentioned in the first quarter of this year, we implemented our protocol and we implemented a protocol amendment to streamline detection of a potential efficacy signal in this trial. As a result of the protocol amendment target enrollment was revised from approximately 132 patients to approximately 93 patients.

    最後,我們的變構 TYK2 抑制劑 VTX958 和中度至重度活動性克隆氏症的 2 期試驗仍在繼續取得進展。正如我們在今年第一季所提到的,我們實施了我們的方案,並實施了方案修訂,以簡化本試驗中潛在功效訊號的檢測。由於方案修訂,目標入組人數從約 132 名患者修改為約 93 名患者。

  • And the trial's sole primary endpoint is now the change from baseline in the main Crohn's disease activity index or CDAI score at week 12. We have completed enrollment in the trial in March, and we look forward to reporting top line results in early second half of 2024.

    該試驗目前唯一的主要終點是第 12 週主要克隆氏症活動指數或 CDAI 評分相對於基線的變化。我們已於 3 月完成了試驗的註冊,我們期待在 2024 年下半年初報告頂線結果。

  • And so in conclusion, I would like to again thank all of our Ventyx team members for their continued efforts and contributions across the pipeline to our investigators collaborators and of course, all the patients that enroll in our trials.

    總之,我想再次感謝我們所有的 Ventyx 團隊成員在整個流程中為我們的研究人員合作者以及所有參與我們試驗的患者所做的持續努力和貢獻。

  • We are very much looking forward to a productive year for Ventyx and to continue to provide these exciting updates. I'll now hand the call back to Marty for a brief review of our financial -- of our corporate first quarter financial results. Marty?

    我們非常期待 Ventyx 能夠迎來富有成效的一年,並繼續提供這些令人興奮的更新。現在,我將把電話轉回給馬蒂,讓他簡要回顧一下我們的財務——我們公司第一季的財務表現。馬蒂?

  • Martin Auster - Chief Financial Officer

    Martin Auster - Chief Financial Officer

  • Thank you, Raju. Our financial results for the first quarter ended March 31, 2024 are presented in our press release issued at market close, and I'll briefly summarize those results here now.

    謝謝你,拉朱。我們截至 2024 年 3 月 31 日的第一季財務業績已在收盤時發布的新聞稿中公佈,我現在將在此簡要總結這些業績。

  • R&D expenses in the quarter were $33.7 million compared to $35.4 million in the first quarter of 2023. G&A expenses in the first quarter of '24 were $8 million compared to $7.1 million for the first quarter of 2023. And our net loss in the first quarter of 2024 was $38.6 million compared to a $38.9 million net loss in the first quarter of 2023.

    本季的研發費用為 3,370 萬美元,而 2023 年第一季的研發費用為 3,540 萬美元。2024 年第一季的一般管理費用為 800 萬美元,而 2023 年第一季為 710 萬美元。我們 2024 年第一季的淨虧損為 3,860 萬美元,而 2023 年第一季的淨虧損為 3,890 萬美元。

  • Our cash, cash equivalents and marketable securities balance was $302.6 million as of March 31, 2024, net cash used in operating activities during the first quarter of $47.6 million was higher than the reported operating expenses of $41.8 million and is primarily due to an increase in prepaid expenses and a decrease in accrued expenses during the quarter.

    截至2024 年3 月31 日,我們的現金、現金等價物及有價證券餘額為3.026 億美元,第一季經營活動使用的現金淨額為4,760 萬美元,高於報告的營運費用4,180 萬美元,主要是由於本季預付費用和應計費用減少。

  • We expected both our operating expenses and our operating cash flows on a quarterly basis to decrease as we get into second quarter of 2024 and remain lower for the rest of 2024 as we complete the wind-down activities related to our Phase 2 trial programs in psoriasis and psoriatic arthritis for VTX958.

    我們預計,隨著進入2024 年第二季度,我們的營運費用和營運現金流量將按季度下降,並在2024 年剩餘時間內保持較低水平,因為我們完成了與銀屑病​​第二階段試驗項目相關的逐步結束活動和 VTX958 的銀屑病關節炎。

  • We continue to believe that our current cash, cash equivalents and marketable securities are sufficient to support our planned operations into at least the second half of 2026.

    我們仍然相信,我們目前的現金、現金等價物和有價證券足以支持我們至少到 2026 年下半年的計畫營運。

  • This concludes our prepared remarks. For this afternoon's call. And I'll now turn the call back to the operator to begin the Q&A session.

    我們準備好的演講到此結束。為了今天下午的電話。現在我將把電話轉回接線生以開始問答環節。

  • On the Q&A session, we'll be joined by Dr. Richie Mohan as well as our Chief Scientific Officer, John Nuss. Operator, please go ahead.

    Richie Mohan 博士和我們的首席科學官 John Nuss 將參加問答環節。接線員,請繼續。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Michael Yee, Jefferies.

    麥可葉,杰弗里斯。

  • Unidentified Participant

    Unidentified Participant

  • Thanks for the question. This is Kyle for Michael. On the CNS-Penetrant NLRP3 program, what do you think is promising for a 28 day study in human or oral like this? And what do you think is the bar and how do you think it stacks up other injectables and or options under investigation?

    謝謝你的提問。這是邁克爾的凱爾。在 CNS 滲透 NLRP3 專案中,您認為像這樣的 28 天人體或口腔研究有什麼前景?您認為標準是什麼?

  • A quick one on your mouse data. Where do you think you're going to present the data, is there going to be in the format of our press release or are you going to report it at the company? Thank you.

    快速了解您的滑鼠資料。您認為您將在哪裡呈現數據,是否以我們新聞稿的格式提供,或您將在公司報告?謝謝。

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Well, thanks so let me let me address the second question first. So will we -- as I mentioned before, we plan to report this data in the late second quarter and we're in the process of compiling the data. And once we have all that together, we'll decide what the right forum for presenting it. So just stay tuned.

    嗯,謝謝,所以讓我先解決第二個問題。我們也會——正如我之前提到的,我們計劃在第二季末報告這些數據,並且我們正在編譯數據。一旦我們把所有這些都整合在一起,我們將決定展示它的正確論壇。所以請繼續關注。

  • In terms of your questions about sort of what we expect to see in 28 days. I think there's plenty of us studies out there, not just with GLP-1 agonists with other modalities as well, showing measurable weight loss in 28 days and in human trials anywhere from a single digits, 2% to a higher weight loss.

    關於您關於我們預計 28 天內會看到什麼的問題。我認為我們有很多研究,不僅是 GLP-1 激動劑與其他方式的研究,在人體試驗中顯示 28 天內可測量的體重減輕,從個位數、2% 到更高的體重減輕。

  • So again, it remains to be seen what the competitor data will show if and when the data are put out, in our mind, we have to deal with two things happening. One is obviously we've done and we are repeating the study that was published in diet-induced obese mice because as we mentioned, it's a monotherapy study with the compound in our control and it's a combination study with semaglutide, and we're looking forward to reporting these results.

    因此,如果競爭對手的數據公佈,以及當數據公佈時,競爭對手的數據將顯示什麼,還有待觀察,在我們看來,我們必須處理正在發生的兩件事。一是顯然我們已經完成了,我們正在重複在飲食誘導的肥胖小鼠中發表的研究,因為正如我們提到的,這是一項我們對照的化合物的單一療法研究,也是一項與索馬魯肽的聯合研究,我們正在尋找期待報告這些結果。

  • We also, as we've said, committed to doing a our own trial, 22 trial in patients, and we think there's biology up there now that certainly links and NLRP3 activation, in addition to our hyper tonic control of obesity will parameters or mechanisms as such as feeding behavior. And I think that body of evidence will continue to grow as folks tried to link the docs just like us have linked the data just like has been happening for Parkinson's disease.

    正如我們所說,我們也致力於進行一項我們自己的試驗,在患者中進行的22 項試驗,我們認為,除了我們對肥胖的高滲透控制參數或機制之外,現在的生物學肯定與NLRP3激活相關。我認為,隨著人們試圖將文件聯繫起來,就像我們將數據聯繫起來一樣,就像帕金森氏症的情況一樣,證據將繼續增長。

  • So we're committed during this trial. We look forward to seeing the data from the competitor if and when it's put out there. But our own path here is planned, which is, again, put out the mouse data and then planning for it Phase 2a study in obese patients, latter half of the year.

    所以我們在這次審判中做出了承諾。我們期待看到競爭對手的數據是否發布。但我們自己的路徑已經規劃好了,即再次公佈小鼠數據,然後計劃在下半年對肥胖患者進行 2a 期研究。

  • Unidentified Participant

    Unidentified Participant

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Yasmeen Rahimi, Piper Sandler.

    亞斯明·拉希米,派珀·桑德勒。

  • Liam Hiester - Analyst

    Liam Hiester - Analyst

  • Hi, this is Liam Hiester on for Yas. So I guess my first question is related to what's the current tox package available for VTX3232.

    大家好,我是亞斯隊的利亞姆·希斯特。所以我想我的第一個問題與 VTX3232 目前可用的毒理學包有關。

  • And then when moving on to the expected Phase 2 trials and what work still needs to be done in order to initiate in obese patients with additional CV risk and then moving to 2735 with those Phase 3 trials, what are the rate-limiting steps in initiating a MACE or recurrent pericarditis on trial there?

    然後,當進入預期的 2 期試驗時,仍然需要做哪些工作才能在具有額外 CV 風險的肥胖患者中啟動,然後進入 2735 期 3 期試驗,啟動時的限速步驟是什麼是MACE還是復發性心包炎試驗有?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • All right. So let me start with the first one. So our first study is a 28 day study. These patients similar study, we are planning with 28 day study and in early Parkinson's disease. And then we will initiate the longer-term studies, in particular, the obesity study, if that merits the Phase 2 in the latter half of the year. So right now the tox package will support a 28 day study and then we'll have the tox coverage to do chronic studies in the latter half of the year.

    好的。那麼讓我從第一個開始。所以我們的第一項研究是為期 28 天的研究。這些患者的研究類似,我們計劃在早期帕金森氏症中進行為期 28 天的研究。然後我們將啟動長期研究,特別是肥胖研究,如果值得在下半年進行第二階段的話。因此,現在毒物包將支持 28 天的研究,然後我們將在下半年進行長期研究的毒物覆蓋範圍。

  • Second question was on briefly, if you don't mind repeating the second one?

    第二個問題很簡短,您不介意重複第二個問題嗎?

  • Liam Hiester - Analyst

    Liam Hiester - Analyst

  • Oh yeah. So I guess like for the 2735 asset, what are the rate-limiting steps for the initiation of the Phase 2 MACE trials and recurrent pericarditis?

    哦耶。所以我想對於 2735 資產來說,啟動 2 期 MACE 試驗和復發性心包膜炎的限速步驟是什麼?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • This does not reflect every child has to have its own individual planning. The teams have to get together, the protocols have to be written and the contracting has to be done. We've laid out our timelines for the Parkinson obesity trial and relay out the timelines for cardiovascular trials once those have been firmed up. The store rate-limiting step is just a part of the planning process on going from Phase 1 study to a Phase 2 study.

    這並不反映每個孩子都必須有自己的個人計畫。團隊必須聚集在一起,必須編寫協議並簽訂合約。我們已經制定了帕金森肥胖試驗的時間表,並在確定後公佈了心血管試驗的時間表。商店限速步驟只是從第一階段研究到第二階段研究的規劃過程的一部分。

  • So it's just standard down process that we have here. But we're pretty excited about cardiovascular opportunities for 2735, both in recurrent pericarditis and also in the secondary prevention of MACE.

    所以這只是我們這裡的標準羽絨流程。但我們對 2735 的心血管機會感到非常興奮,無論是在復發性心包膜炎還是在 MACE 的二級預防方面。

  • Liam Hiester - Analyst

    Liam Hiester - Analyst

  • Great. And then actually just one more question. So with VTX002, just wondering if you could provide any more detail on the level of partnership interest and then also any details from the Phase 2 meetings?

    偉大的。然後實際上還有一個問題。那麼對於 VTX002,只是想知道您是否可以提供有關合作夥伴興趣程度的更多詳細信息,以及第二階段會議的任何詳細信息?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah. On the end-of-Phase 2 meeting, we had a really good meeting with the FDA and we laid our justification for a Phase 3 trial with the single dose. And we believe this should serve as a pivotal trial, as should the first one. And we'll have continue to have a discussion with the agency as this trial progresses. So in our mind, a very successful meeting with the FDA.

    是的。在第二階段會議結束時,我們與 FDA 進行了一次非常愉快的會議,並為單劑量第三階段試驗奠定了理由。我們相信,這應該是關鍵的試驗,就像第一個試驗一樣。隨著試驗的進展,我們將繼續與該機構進行討論。所以在我們看來,與 FDA 的會議非常成功。

  • In terms of partnerships, we're not going to get into specifics. We think this compound continues to show a very strong endoscopic remission as we showed from the open label, we believe the long-term extension data will continue to support both the durability of this and perhaps even improved scores such as a precedent with S1P1 modulators.

    在合作關係方面,我們不打算討論具體細節。我們認為這種化合物繼續表現出非常強的內視鏡緩解,正如我們從開放標籤中所顯示的那樣,我們相信長期擴展數據將繼續支持其耐久性,甚至可能提高分數,例如S1P1 調節劑的先例。

  • And as Per said, we are aggressively in the midst of getting interest from pharma partners across a wide range of folks and stay tuned, and we'll update you guys once those things progress to something that we can talk about.

    正如 Per 所說,我們正在積極吸引廣大製藥合作夥伴的興趣,請關注,一旦這些事情進展到我們可以討論的程度,我們將向你們通報最新情況。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • Kimberly Bodnar with H.C. Wainwright.

    博德納爾 (Kimberly Bodnar) 和 H.C.溫賴特。

  • Kimberly Bodnar - Analyst

    Kimberly Bodnar - Analyst

  • Hi, thanks for taking the question. For Parkinson's disease I'm curious if you can comment on what kind of neurodegenerative markers you're planning to evaluate and if you're looking at any of these rating scores or could have impacts on motor symptoms? And maybe if you could provide a bit more on study design for obesity interim, like how many patients you're planning to evaluate? And are you planning to exclude diabetes patients in that study?

    您好,感謝您提出問題。對於帕金森氏症,我很好奇您是否可以評論您計劃評估哪種神經退化性標記物,以及您是否正在查看這些評分中的任何一個或可能對運動症狀產生影響?也許您可以提供更多有關肥胖症中期研究設計的信息,例如您計劃評估多少患者?您打算在該研究中排除糖尿病患者嗎?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah, good questions. So again, on specifics of the trial, and we're not trying to be cagey. We don't Mr. disclose every aspect of this trial. Once we have it will be on ClinicalTrails.gov. But again, just to bring it in context, you saw the competitors are 28-day trial within NRT to compound a few months back. They published a biomarker trial.

    是的,好問題。再說一次,關於試驗的具體細節,我們並不是想保持謹慎。先生,我們不會透露這次審判的各個方面。一旦我們有了它,就會出現在 ClinicalTrails.gov 上。但再次強調一下,幾個月前,您看到競爭對手在 NRT 中進行了 28 天的試驗以進行複合。他們發表了一項生物標記試驗。

  • We are planning not just a biomarker trial, but we also have an imaging component of this trial to see effects of this molecule on glial content and activation as it translates into eventual effects in astrocytes and eventually neuronal death. Don't expect much effect on motor symptoms in these short trials, but we certainly expect to see effects on.

    我們不僅計劃進行生物標記試驗,而且還計劃進行該試驗的成像部分,以觀察該分子對神經膠質含量和活化的影響,因為它會轉化為星形膠質細胞的最終影響並最終導致神經元死亡。在這些短期試驗中,不要期望對運動症狀有太大影響,但我們當然希望看到效果。

  • Number one, is the NLRP3 related biomarkers such as IL-1 beta, hsCRP, IL-6 fibrinogen, we've shown them now, convincingly in multiple trials. Even in early phase 1. We've seen some movement in these trials and these markers even in healthy volunteers. We certainly showed a robust response often NLRP3 compound, albeit the peripheral one in hsCRP. and again IL-1 beta and IL-6.

    第一,是 NLRP3 相關的生物標記物,例如 IL-1 beta、hsCRP、IL-6 纖維蛋白原,我們現在已經在多項試驗中令人信服地展示了它們。即使在第一階段的早期。我們在這些試驗中看到了一些變化,甚至在健康志願者中也看到了這些標記物的變化。我們當然對 NLRP3 化合物表現出強烈的反應,儘管是 hsCRP 中的外周反應。再次是 IL-1 β 和 IL-6。

  • And in the Phase 1 trial with 3232, we also showed effects on these biomarkers, even in healthy volunteers and in the CSF, right. So those are all those are NLRP3 related biomarkers. And then you have the other side of neurodegenerative markers, in particular, with Parkinson's patients such as neurofilament light chain and others and again, thoughtfully explore a range of biomarkers there. Nothing that precludes us from having a much broader set in our measuring strategy.

    在 3232 的 1 期試驗中,我們也顯示了對這些生物標記的影響,甚至在健康志願者和腦脊髓液中也是如此,對吧。這些都是 NLRP3 相關的生物標記。然後你還有神經退化性標記物的另一面,特別是帕金森氏症患者的神經絲輕鍊等,並再次仔細探索那裡的一系列生物標記。沒有什麼可以阻止我們制定更廣泛的衡量策略。

  • But again, we're not setting an expectation of seeing any sort of meaningful effects of the short trial, and that's why we have a longer trial that we are contemplating towards the end of the year, which will be much more in line with what you've seen recently or published for much longer treatment in Parkinson's patients. And these are 12 months or longer trials.

    但同樣,我們並沒有期望看到短期試驗產生任何有意義的影響,這就是為什麼我們正在考慮在今年年底進行更長的試驗,這將更符合我們的預期。金森病患者的長期治療。這些是 12 個月或更長時間的試驗。

  • Kimberly Bodnar - Analyst

    Kimberly Bodnar - Analyst

  • Makes sense. Thank you.

    說得通。謝謝。

  • Operator

    Operator

  • Vikram Purohit, Morgan Stanley.

    維克拉姆‧普羅希特,摩根士丹利。

  • Gospel Enyindah-Asonye - Analyst

    Gospel Enyindah-Asonye - Analyst

  • Hi, everyone. On this as Gospel on for Vikram. We have one question regarding your CD program, what is the hurdle for continuing on VTX958 in Crohn's disease based on the data expected in the second half of the year?

    大家好。這對維克拉姆來說是個福音。我們有一個關於你們的 CD 計劃的問題,根據下半年預計的數據,繼續使用 VTX958 治療克羅恩病的障礙是什麼?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah, thanks Vikram. And perhaps, I'll let Marty address this. Marty?

    是的,謝謝維克拉姆。也許,我會讓馬蒂解決這個問題。馬蒂?

  • Martin Auster - Chief Financial Officer

    Martin Auster - Chief Financial Officer

  • Yeah, thanks for the question, Gospel. So for that trial, the primary endpoint is a change in CDAI score. And then we're looking at key secondary endpoints that include like endoscopic response and things like that.

    是的,謝謝你的問題,福音。因此,對於該試驗,主要終點是 CDAI 評分的變化。然後我們正在研究關鍵的次要終點,包括內視鏡反應等。

  • If you look across sort of approved drugs in the currency space, you're looking at some of the biologics as well as more recently developed products like Upadacitinib. You'll see CDAI changes in the Phase 2 in the range of the upper double digits to kind of low hundreds as sort of a some kind of a meaningful type of response on that marker on we're adequately powered to sort of detect statistical significance in that type of response.

    如果您查看貨幣領域已批准的藥物種類,您會看到一些生物製劑以及最近開發的產品,例如 Upadacitinib。您將看到 CDAI 在第二階段的變化,範圍從高位兩位數到低位數百位,這是對該標記的某種有意義的響應類型,我們有足夠的能力來檢測統計顯著性在那種類型的回應中。

  • And then on the endoscopic side, that's a secondary endpoint given the size of the trial. But we'd be looking to see sort of, again something competitive there would be in the high teens to low 20s on endoscopic response versus relative delta versus placebo. So that's sort of kind of, I think where the bar is for recently approved drugs to be attractive in this setting. So we're looking forward to reporting those results out here in the next several months.

    然後在內視鏡方面,考慮到試驗的規模,這是次要終點。但我們希望看到內視鏡反應與相對德爾塔與安慰劑相比,在十幾歲到二十幾歲之間有競爭力的東西。所以,我認為最近批准的藥物在這種情況下具有吸引力的門檻在哪裡。因此,我們期待在接下來的幾個月內在這裡報告這些結果。

  • Gospel Enyindah-Asonye - Analyst

    Gospel Enyindah-Asonye - Analyst

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Alex Thompson, Stifel.

    亞歷克斯湯普森,斯蒂菲爾。

  • Alexander Thompson - Analyst

    Alexander Thompson - Analyst

  • Hey great, thanks for taking my questions. I guess first one on 3232 to follow-up a little bit on the DIO mask experiments. Can you talk a little about sort of the you mean dose equivalents are going to be testing relative to what you're looking for in the Phase 2 and what you want to see in both the monotherapy and combo studies to get more confident in the human trial.

    嘿,太好了,謝謝你回答我的問題。我想第一個是在 3232 上進行的,是為了跟進 DIO 遮罩實驗。您能否談談您在第二階段中尋找的劑量當量以及您希望在單一療法和組合研究中看到的劑量當量,以便對人類更有信心審判。

  • And then for 2735 just curious your thoughts on peripheral and NLRP3 inhibition in the context of what we saw from lutikizumab at AAD and whether you would consider an indication like HS in the future? Thanks.

    然後,對於 2735,我們只是想知道您對週邊血液和 NLRP3 抑制的看法,以及我們在 AAD 中從 lutikizumab 中看到的情況,以及您將來是否會考慮像 HS 這樣的適應症?謝謝。

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah. So first, on human dose equivalent in the mouse study, so the mouse we don't do the studies in rodent programs whether it's for an NLRP3 for Europe or anything else, that's really a proof of concept and you appropriately dosed the animals based on the profile of that compound in mice for example, right. So the exposure in mice, the potency of the compound in, for example, against mouse NLRP3.

    是的。首先,關於小鼠研究中的人類劑量當量,因此我們不會在囓齒動物項目中進行小鼠研究,無論是歐洲的 NLRP3 還是其他項目,這確實是一個概念證明,您根據例如,該化合物在小鼠體內的分佈情況,右。因此,在小鼠中暴露後,該化合物的效力,例如針對小鼠 NLRP3 的效力。

  • And that's the goal. It's not determined the human dose. Remember, we've done a Phase 1 trial with biomarkers in plasma and in CSF, we've calibrated that trial with what we expect to have the exposure to cover IL-1 beta IC50, IL-1 beta IC90.

    這就是目標。尚未確定人體劑量。請記住,我們已經對血漿和腦脊髓液中的生物標記進行了 1 期試驗,我們已經根據我們預期的暴露範圍校準了該試驗,以覆蓋 IL-1 beta IC50、IL-1 beta IC90。

  • And if IL-1 beta is a driver or IL-18, but IL-1 beta and IL-18 are the drivers of the disease pathologies, and that's the calibrations, what doses do we need in humans to then have complete abrogation of complete inhibition of the IL-1 beta produced by an NLRP3 in periphery or in the CNS in the CSF as a good surrogate.

    如果 IL-1 β 是驅動因素或 IL-18,但 IL-1 β 和 IL-18 是疾病病理學的驅動因素,這就是校準,我們需要在人類中使用什麼劑量才能完全消除抑制外周或腦脊髓液中CNS 中的NLRP3 產生的IL-1 β,作為良好的替代品。

  • So, just to make it clear, the mouse studies are not meant to find doses for a new obesity trial of a Parkinson's trial for any other Phase 2 trial.

    因此,需要澄清的是,小鼠研究並不意味著為任何其他 2 期試驗尋找帕金森氏症試驗的新肥胖試驗劑量。

  • So in terms of mice, again, the doses are now set to make sure that we have adequate coverage in the mice to see effects on weight losses, see effects on other endpoints. And it again depends on the compound. So we don't take any sort of guidelines from the competitor dosing paradigm, in which case it was three times a day in mice.

    因此,就小鼠而言,現在設定劑量是為了確保我們對小鼠有足夠的覆蓋範圍,以觀察對體重減輕的影響,以及對其他終點的影響。這又取決於化合物。因此,我們沒有從競爭對手的劑量範式中獲得任何指導原則,在這種情況下,對小鼠的劑量為每天三次。

  • We have our own dosing regimen, and that's what we've done in both trials, the monotherapy and the combo therapy. I think the expectation that you have with the question you had is what do we expect to see in a combination trial.

    我們有自己的給藥方案,這就是我們在兩個試驗中所做的:單一療法和聯合療法。我認為你對你所提出的問題的期望是我們期望在組合試驗中看到什麼。

  • First of all, we this whole trial, the old study from, call it a trial in mice was ready to have our own calibration of our compound, which is a really well-behaved CNS drug. I think the best behaved CNS penetrant compound out there in the NLRP3 class.

    首先,我們整個試驗,即舊的研究,稱之為小鼠試驗,已經準備好對我們的化合物進行自己的校準,這是一種表現良好的中樞神經系統藥物。我認為 NLRP3 類中表現最好的中樞神經系統滲透劑化合物。

  • And so our goal is to set our own calibration in terms these mice models, which we believe are in different parameters, predictive of human disease. So is that a one-to-one mouse model is a human model. It's different aspects and different readouts from this study, recapitulate what you expect in human studies, right in this case obesity.

    因此,我們的目標是根據這些小鼠模型設定我們自己的校準,我們相信這些模型具有不同的參數,可以預測人類疾病。一對一的小鼠模型也是人類模型。這項研究的不同面向和不同讀數,概括了您在人類研究中所期望的內容,在本例中是肥胖。

  • So having no expectations of having the competitive data, we designed this trial with that compound with the semaglutide control with additive and with adequate controls with a placebo first thing to see whether you see weight loss with our compound obviously have weight loss on semaglutide that's been published many times, that have published in the competitor compound, data that you saw, next thing is to understand effective weight-loss, affect of food intake and then once the study is completed, what happens to other parameters, lipid parameters, what happens to diabetes parameters like glucose, insulin, OGTT, HOMA-IR, what's happening to steatosis.

    因此,我們不期望獲得有競爭力的數據,因此我們設計了該試驗,使用該化合物與帶有添加劑的索馬魯肽對照和帶有安慰劑的充分對照,首先看看您是否看到我們的化合物的體重減輕明顯與索馬魯肽的體重減輕有關發表過很多次,在競爭對手的化合物中發表過,你看到的數據,下一步是了解有效的減肥,食物攝入的影響,然後一旦研究完成,其他參數會發生什麼,血脂參數會發生什麼糖尿病參數,如葡萄糖、胰島素、OGTT、HOMA-IR、脂肪變性的情況。

  • So as we know, obesity or reduction in obesity results in benefit on a number of parameters, so we'd look for that. In the combo study, obviously, we would look for not just the effects of monotherapy, but what is the effect of NLRP3 inhibition on weight loss vis=a-vis the semaglutide alone or GLP agonist alone is it additive or synergistic. Eventually we'd like to understand this mechanism as our partner. So again, this is the mouse studies are really of a way to build like the in vitro studies, a lot of links and in understanding this pathway, right?

    據我們所知,肥胖或肥胖的減少會對許多參數帶來好處,所以我們會尋找這一點。顯然,在組合研究中,我們不僅要尋找單一療法的效果,還要尋找 NLRP3 抑制相對於單獨的索馬魯肽或單獨的 GLP 激動劑對體重減輕的影響,它是相加的還是協同的。最終我們希望作為我們的合作夥伴來了解這個機制。再說一次,這就是小鼠研究確實是一種像體外研究一樣建立起來的方法,有很多聯繫並理解這個途徑,對嗎?

  • So we've built we've done some work in the microbial cells. We'll get data from the mouse studies. And then obviously, we're committed to doing the human study. But this is pretty exciting stage in this part of the NLRP3 pathway strategy always been interested in Parkinson's, but this has opened up a whole new area. And I think we're sort of in the forefront of this with our molecule to be able to sort of connect the dots. And we're looking forward to sharing the mouse data with you guys in a few weeks ended the end of the second quarter.

    所以我們已經在微生物細胞中做了一些工作。我們將從小鼠研究中取得數據。顯然,我們致力於進行人體研究。但這是非常令人興奮的階段,NLRP3通路策略的這一部分一直對帕金森氏症感興趣,但這開啟了一個全新的領域。我認為我們的分子處於這方面的前沿,能夠將這些點連接起來。我們期待在第二季末結束的幾週內與大家分享滑鼠數據。

  • I think your third question was, potential for 2735 in HS, yeah, so we think there's potential -- clear potential for a 2735 mechanism in HS.

    我認為你的第三個問題是,HS 中 2735 的潛力,是的,所以我們認為 HS 中 2735 機制有潛力 - 明顯的潛力。

  • I'd just caution you that the results from the AbbVie study were very, very encouraging, isn't a real one-to-one correspondence between a IL-1 beta antibody such as canakinumab and NLRP3 mechanism versus the AbbVie, it's an IL-1 alpha/beta antibody as well as, for example, a IL-1 alpha beta trap such as sort of separate that a little bit of a area that it has to be explored but yeah, certainly there is a and that's rationale for looking at NLRP3 molecule in HS.

    我只是提醒您,AbbVie 研究的結果非常非常令人鼓舞,IL-1 beta 抗體(如卡那奴單抗)和 NLRP3 機制與 AbbVie 之間並不是真正的一一對應關係,它是一種 IL - 1 α/β 抗體以及,例如,IL-1 α β 陷阱,例如某種獨立的、必須探索的一點區域,但是,是的,當然存在一個,這就是尋找的理由HS 中的 NLRP3 分子。

  • Operator

    Operator

  • Derek Archila, Wells Fargo.

    德里克·阿奇拉,富國銀行。

  • Derek Archila - Analyst

    Derek Archila - Analyst

  • Thanks for taking your questions. I guess a couple of (technical difficulty) Phase 1 data in your NT-0796 positive outcome in thier phase 1b/2a, do you think getting to Phase 2b trial is now de-risked? And then also, do you expect 3232 to differentiate from NT-0796 in Parkinson's?

    感謝您提出問題。我猜您的 NT-0796 1b/2a 期陽性結果中有一些(技術難度)1 期數據,您認為現在進入 2b 期試驗的風險是否已降低?另外,您是否期望 3232 在帕金森氏症治療中能夠與 NT-0796 區分開來?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah. So sorry, you're fading out a little bit. So your question was, has the data from NodThera in their Parkinson's Phase 2a derisked our trial, that was the question?

    是的。很抱歉,你有點淡出。所以你的問題是,NodThera 在帕金森氏症 2a 期的數據是否會影響我們的試驗?

  • Yeah, so let me assume that's a question. So it's always good to see you. It's always good to see data from a in any drug in the class where there hasn't been a lot of data out there showing effects on on biomarkers in this study, right.

    是的,所以讓我假設這是一個問題。所以很高興見到你。很高興看到該類藥物中任何藥物的數據,但在本研究中還沒有大量數據顯示其對生物標記的影響,對吧。

  • But again for us, we believe from our Phase 1 study, everything we've seen this is an extremely well-behaved compound. It's suitable for QD dosing at low doses. We expect to have coverage of IC90 at doses starting at 10 to 12 milligrams to real clean single order kinetics dosing profile.

    但對我們來說,從第一階段研究來看,我們相信,我們所看到的一切都是一種表現極為良好的化合物。它適合低劑量的 QD 給藥。我們預計從 10 至 12 毫克開始的劑量就能達到 IC90,達到真正乾淨的單級動力學劑量曲線。

  • So we're looking forward to this 28 day study engineered on data. Like I said, I don't have any, and I doubt that we'll see effects on IL-1 beta downstream markers and NLRP3, again, IL-1 beta and IL-6, hsCRP, and then we'll establish our own biomarker profile, both in blood and in CSF with respect to things like neurofilament light chain and other biomarkers.

    因此,我們期待這項為期 28 天的基於數據的研究。就像我說的,我沒有任何影響,我懷疑我們是否會看到對 IL-1 beta 下游標記和 NLRP3 的影響,同樣,IL-1 beta 和 IL-6,hsCRP,然後我們將建立我們的自己的生物標記概況,包括血液和腦脊髓液中的神經絲輕鍊和其他生物標記。

  • Well, then there was some data from NodThera. But our compound is so well behaved. We have we hit the target so hard that will have to set our own calibration for the Phase 2a before we go into a longer Phase 2 study.

    那麼,NodThera 提供了一些數據。但我們的院落表現得很好。我們已經如此努力地實現了目標,以至於在進入更長的第 2 階段研究之前,我們必須為第 2a 階段設定自己的校準。

  • Derek Archila - Analyst

    Derek Archila - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Samuel Slutsky, LifeSci.

    塞繆爾‧斯盧茨基,《生命科學》。

  • Samuel Slutsky - Analyst

    Samuel Slutsky - Analyst

  • Hey good afternoon, everyone. I hopped on a tad late. So if you answered any my questions previously, just let me know. On the obesity preclinical study with 3232, just kind of generally speaking, how similar or different methodology to what they're doing in their preclinical study.

    嘿大家下午好。我跳得有點晚了。因此,如果您之前回答過我的任何問題,請告訴我。關於 3232 的肥胖症臨床前研究,一般來說,他們在臨床前研究中所做的方法有多麼相似或不同。

  • And then do you anticipate that there will be any bigger conclusion drawn from it other than kind of the final area of it looks good or not on and weight loss?

    然後你預計除了它的最終部分看起來好壞和減肥之外,還會得出任何更大的結論嗎?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah, good to hear from you, Sam, and happy to repeat the answers for you. I don't wanting us never like 30 years spent so much time talking about mice studies, but happy to do so.

    是的,很高興收到你的來信,Sam,並且很高興為你重複答案。我不希望我們像 30 年來那樣花這麼多時間談論小鼠研究,但很高興這樣做。

  • And it's -- so there's really no learnings from from the mouse study that the competitor did and give us a pretty standard dial study. So you have obese mice. And in olden days you had to to to generate these mice by feeding them a high-fat diet for 15 weeks or longer.

    因此,競爭對手所做的滑鼠研究確實沒有為我們帶來任何教訓,並為我們提供了相當標準的錶盤研究。所以你有肥胖的老鼠。在過去,你必須透過餵食高脂肪飲食 15 週或更長時間來培育這些老鼠。

  • Now these things are off the shelf. You can buy, obese mice, diet-induced obese mice in terms of -- so we have done these trials before perhaps looking at different endpoints. In this case, the primary endpoint obviously is weight loss. And we look at secondary endpoints, as I mentioned before, the effects on liver weight, body weight, body scan. We have been also doing dexan in the study, look at lipids, we look at the liver steatosis. We do in the liver. So everything that you would want to read out post the reclass there as well.

    現在這些東西都已經下架了。你可以購買肥胖小鼠,飲食誘導的肥胖小鼠——所以我們在研究不同的終點之前已經完成了這些試驗。在這種情況下,主要終點顯然是體重減輕。正如我之前提到的,我們專注於次要終點,即對肝臟重量、體重、身體掃描的影響。我們也在研究中進行了右旋糖酐,觀察血脂,觀察肝臟脂肪變性。我們在肝臟中進行。因此,您在重新分類後想要讀出的所有內容也都在那裡。

  • Really again, like I said before, you need to look at individual readings from this study to understand, how it translates or potentially translates into what you expect in humans is not a one-to-one correlation. I just love this model used for a number of things. You'll see them being used for developing drugs for diabetes. They've been used for DPP-4 inhibitors, they have been used for SGLT2. They've been used for GLP-1 agonist. Now they're looking at NLRP3. So it's really a broad model and you can take individual pieces from this model and then reconstruct what you would want to see in a human study, right.

    真的,就像我之前說過的,你需要查看這項研究中的個人解讀,才能理解它如何轉化或可能轉化為你對人類的期望,這並不是一對一的相關性。我只是喜歡這個模型用於很多事情。您會看到它們被用於開發糖尿病藥物。它們已用於 DPP-4 抑制劑,也已用於 SGLT2。它們已被用於 GLP-1 激動劑。現在他們正在研究 NLRP3。所以它確實是一個廣泛的模型,你可以從這個模型中取出各個部分,然後重建你想要在人類研究中看到的東西,對吧。

  • And again, we're excited about not just this model. This model does just a path for us to go into humans. And so, we'll complete the models will get you the data in two weeks. And then onto the human study. And in the meantime, our biologists are actively trying to link the dots in understanding hypothalamic interaction with NLRP3 and effects on downstream, so just trying to build a picture.

    再說一遍,我們不僅對這個模型感到興奮。這個模型只是為我們進入人類做了一條道路。因此,我們將完成模型,並在兩週內為您提供數據。然後進入人類研究。同時,我們的生物學家正在積極嘗試將各個點聯繫起來,以了解下丘腦與 NLRP3 的相互作用以及對下游的影響,因此只是試圖建立一幅圖景。

  • Samuel Slutsky - Analyst

    Samuel Slutsky - Analyst

  • Okay, that's helpful. And just real quick on 2735 on the potential prevention of MACE and pericarditis study. As you think about that landscape unmet need current treatment paradigm? Where do you see the profile 2735 kind of best slotting in?

    好的,這很有幫助。很快就進行了 2735 項關於潛在預防 MACE 和心包膜炎的研究。您認為未滿足的景觀需要目前的治療模式嗎?您認為設定檔 2735 的最佳位置在哪裡?

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yes. Let me let me have Marty. Just we've talked a lot about thematically interest for you, Marty?

    是的。讓我讓馬蒂來吧。馬蒂,我們剛剛談了很多關於您感興趣的主題?

  • Martin Auster - Chief Financial Officer

    Martin Auster - Chief Financial Officer

  • Yeah, sure, Sam. So obviously, there's some evolution in some of the management of cardiovascular disease. And so that'll sort of mature over the time course that we're developing 2735. I think in the recurrent pericarditis side, you have a pretty classic sort of niche orphan indication with limited therapeutic options currently rely on us. That's really your sort of your go-to for difficult to manage refractory patients.

    是的,當然,薩姆。顯然,心血管疾病的一些治療方法已經發生了一些變化。隨著我們開發 2735 的時間推移,它會逐漸成熟。我認為在復發性心包膜炎方面,有一種非常經典的孤兒適應症,目前我們依賴的治療選擇有限。對於難以管理的難治性患者來說,這確實是您的首選。

  • It's obviously a it may be less than less than perfect for some patients due to its nature is an injectable therapeutic. It's also a very expensive therapeutics. There's some opportunities certainly to come to any put forth an oral option for patients who are suffering with recurrent pericarditis symptoms.

    顯然,由於其本質是一種注射療法,因此對於某些患者來說可能不太完美。這也是一種非常昂貴的療法。當然,有一些機會可以為患有復發性心包膜炎症狀的患者提供口服選擇。

  • I think that disease often manage now with sort of sort of a bit more of a scattered approach without missing a lot of consistency in treatment guidelines and people use things like aspirin and steroids and culture seeing and things like that. And I think a very nice targeted in our NLRP3 inhibitor from such as 2735 could play an important role.

    我認為現在疾病通常透過一種更分散的方法來控制,而不會失去治療指南的一致性,人們會使用阿斯匹靈和類固醇以及文化觀察等類似的東西。我認為我們的 NLRP3 抑制劑(例如 2735)中的一個非常好的目標可以發揮重要作用。

  • And obviously, the clinical pathways heavily de-risked by the success of our one driven biologics in setting. So excited to kind of develop that and find the right filing for that in the treatment paradigm.

    顯然,我們的單一驅動生物製劑在環境中的成功大大降低了臨床路徑的風險。很高興能夠開發這一點並在治療範例中找到合適的文件。

  • Samuel Slutsky - Analyst

    Samuel Slutsky - Analyst

  • Got it. Thanks, everyone.

    知道了。感謝大家。

  • Operator

    Operator

  • Thank you. We have no further questions at this time. I now turn the presentation back over to Dr. Raju Mohan for any additional or closing remarks.

    謝謝。目前我們沒有進一步的問題。我現在將簡報轉回拉朱莫漢 (Raju Mohan) 博士以供補充或結束語。

  • Raju Mohan - President, Chief Executive Officer, Founder, Director

    Raju Mohan - President, Chief Executive Officer, Founder, Director

  • Yeah. Thank you, everybody, and thank you to all on the call. So thank you for your continued interest in Ventyx is obviously a very exciting period for us. We look forward to connecting with you at the investor conference in the coming months. Connecting with you on the mice data, we are looking forward to talking about our efforts with our two partnerships moving towards the Phase 3 trial and then hopefully reporting on in coming back and reporting on the ongoing Crohn's trial.

    是的。謝謝大家,也謝謝所有參加電話會議的人。感謝您對 Ventyx 的持續關注,這對我們來說顯然是一個非常令人興奮的時期。我們期待在未來幾個月的投資者會議上與您聯繫。我們期待與您就小鼠數據進行交流,討論我們與兩個合作夥伴在第三階段試驗方面所做的努力,然後希望能在回來後報告正在進行的克羅恩病試驗。

  • So a lot to talk about but again for today thank you all, and thank you to the team.

    有很多話要說,但今天再次感謝大家,也感謝團隊。

  • Operator

    Operator

  • Thank you, everyone. This concludes today's teleconference. We appreciate your participation. You may disconnect your lines.

    謝謝大家。今天的電話會議到此結束。我們感謝您的參與。您可以斷開線路。