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Operator
Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to Aquinox Pharmaceuticals second-quarter 2015 conference call.
At this time, all participants are in a listen-only mode. Following the conclusion of the prepared remarks, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, today's call is being recorded.
At this point I would now like to turn the call over to Mr. Brendan Payne, Senior Manager of Investor Relations. Please begin.
Brendan Payne - Senior Manager, IR
Good afternoon and thank you for joining us. On behalf of Aquinox, I would like to welcome everyone to our conference call to discuss the positive results of our secondary endpoints from our Phase 2 LEADERSHIP trial in bladder pain syndrome/interstitial cystitis, or BPS/IC, as well as our Q2 financial results.
Joining me today are Mr. David Main, President and CEO; Dr. Stephen Shrewsbury, Chief Medical Officer; and Mr. Kam Alam, VP of Finance and CFO.
For the purpose of the LEADERSHIP results portion of today's call, we will be specifically referring to and guiding you through a slide presentation filed earlier today with the SEC and can be viewed as a webcast from the events page of our website at www.aqxpharma.com. A link to participate in this webcast can also be found in our press release issued earlier today and these slides will be posted to our website following the completion of today's call.
During today's call, Mr. Alam will begin by discussing our second-quarter 2015 financial results. Mr. Main will then present a brief business update and revisit the top-line results of the LEALDERSHIP trial that were reported on June 25. Dr. Shrewsbury will then review the new results from secondary endpoints in the LEADERSHIP trial. Mr. Main will close with the discussion of the significance of these results to Aquinox.
Today's conference call will include forward-looking statements under the Private Securities Litigation Reform Act of 1995, including statements regarding our research and development plans and financial outlook. Actual results may differ from those indicated by these forward-looking statements due to numerous factors, including those discussed in the risk factors section of our most recent 10-Q and other SEC filings.
Our expectations and assumptions could change. While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change.
With that, I would now turn the call over to Kam.
Kam Alam - VP, Finance & CFO
Thank you, Brendan. Research and development expenses for the second quarter of 2015 declined to $3.6 million from $4.6 million in the second quarter of 2014. The decline was the result of reduced expenditures as we approached the completion of the LEADERSHIP and FLAGSHIP trials.
General and administrative expenses of $1.2 million for the second quarter of 2015 were similar to the $1.1 million of G&A expenses for the second quarter 2014. Our net loss for the second quarter of 2015 was $4.8 million compared to a net loss of $5.4 million for the second quarter of 2014. This decline in net loss reflected the decrease in research and development expenses.
Overall, our financial results were in line with our expectations for the activities we had planned during the period.
As we reported in our press release, cash, cash equivalents, and investments totaled $29.0 million as of June 20, 2015, compared to $4.1 million as of December 31, 2014. This decrease was primarily driven by the advancement of AQX-1125 through the FLAGSHIP, LEADERSHIP, and KINSHIP clinical trials. Aquinox expects its cash to be sufficient to continue its operations and fund currently planned activities through the second quarter of 2016.
With that, I will turn the call over to David.
David Main - President & CEO
Thank you, Kam. Good afternoon, everyone, and thank you for joining us.
Before moving into the LEADERSHIP results, I would first like to recap some other important recent events. We have now reported top-line results from both LEADERSHIP and FLAGSHIP Phase 2 clinical trials with AQX-1125. Our FLAGSHIP trial in COPD reported on July 9 that we demonstrated no difference between AQX-1125 and placebo in patients with frequent exacerbations. Consequently, at this time I want to reiterate we have no further development plans for COPD.
We are, however, also nearing completion of the ongoing KINSHIP trial with AQX-1125 in atopic dermatitis and I am pleased to announce that we now expect data to be available in Q4 of this year, earlier than our previous guidance of the end of first quarter 2016. So now on to the important news that I'm sure you all really wanted to get into. I will turn our attention to our update on the LEADERSHIP trial and to explain why we are genuinely excited about this clinical indication and why it warrants our full attention and focus.
We will now begin to use the slide materials to help review the available data.
As a reminder, on slide 3, our Phase 2 LEADERSHIP trial investigated AQX-1125's ability to reduce pain and urinary symptoms in 69 women with BPS/IC. Specifically, LEADERSHIP examined whether a 200-milligram capsule of AQX-1125 taken orally once daily for six weeks could relieve pain and other symptoms as compared to placebo. Patients had to demonstrate, on average, minimum pain score of 5 on an NRS scale of zero to 10, with 10 being severe pain, to be eligible for the trial. So we were enrolling a population of women suffering moderate to severe pain, despite taking other available therapies.
Importantly, to be enrolled in LEADERSHIP, patients were also required to have moderate to severe urinary symptoms as measured on questionnaires. Also, a key eligibility criteria was the observation of inflammation from cystoscopy within the preceding 36 months. So together these enrollment criteria insured that we enrolled patients truly suffering from moderate to severe chronic pain, frequent urinary symptoms, and had been observed to have objective evidence of bladder inflammation.
The primary endpoint of the LEADERSHIP trial was changed from baseline and the average daily bladder pain score based on the 11-point numeric scale, or the NRS scale, at six weeks. The LEADERSHIP trial also included several prespecified secondary endpoints comprised of additional validated measures of pain and other urological symptoms. Among these secondary endpoints were the average daily pain recorded at prespecified clinic visits, the maximum daily pain recorded by the patient on their electronic diaries, the O'Leary-Sant interstitial cystitis symptom and problem indices, the bladder pain syndrome symptom score, as well as patient-recorded bladder voiding frequency.
Of course, there will be additional secondary endpoints and exploratory analysis available from the trial, but those are still under evaluation and we are reserving these for a presentation at a future medical meeting.
On this next slide you will recall from our announcement on June 25 that LEADERSHIP narrowly missed statistical significance on the primary endpoint of average daily pain recorded by e-diary with a P value of 0.061. However, we believe the treatment difference was very informative for a trial of this size and the positive trend towards reduction in pain from baseline with AQX-1125 compared to placebo at six weeks was reassuring.
As we will be discussing today, that encouraging trend has been reinforced by consistently positive results from multiple secondary endpoints, several of which are statistically significant. These results are particularly important because the trial was not powered to show significance on secondary endpoints.
Moving on, also on June 25 we reported that approximately 49% of patients receiving AQX-1125 demonstrated a 2 point or greater reduction in pain compared to 34% of patients receiving placebo. This is illustrated here on the cumulative distribution plot on slide 5 with AQX-1125 shown in blue and placebo in red. As you can see, the plot displays how a greater proportion of patients consistently achieved superior pain reduction with AQX-1125 compared to placebo.
As I have alluded to, since the top-line data announcement, which I've just now we re-reviewed, we have completed many of the secondary endpoint analysis prespecified at the outset of the trial. There is still work ongoing, but we believe the endpoints that have been analyzed to date are the most telling and clinically relevant. Taken together, the results paint a compelling picture for AQX-1125.
I will now turn the call over to Steve, who will take you through the finer details of the secondary endpoints and the significance of both the strength and direction of the results. Steve?
Stephen Shrewsbury - SVP, Clinical Development & Chief Medical Officer
Thank you, David. I am excited to share with you today the additional positive results from the secondary endpoints of our LEADERSHIP trial.
Slide 7 shows a new representation of the primary endpoint, how the average daily pain scores changed as the trial progressed at each two-week clinic visit. Previously we reported solely the result at six-week visit, as shown in the red box, which was the prespecified primary endpoint. As early as two weeks, however, after treatment had commenced, pain scores for patients receiving AQX-1125 started to diverge from placebo and continued to diverge over time.
This increasing separation suggests that a longer and/or larger trial may have achieved our statistical goal. Given this encouraging trend in our primary efficacy endpoint, we early recognized that secondary endpoint analyses would be, and indeed have been, critical in assessing the overall benefit of AQX-1125 to BPS/IC patients.
On slide 8, the NRS pain data was collected for an additional four-week follow-up period beyond the six weeks of treatment. Upon completion of the six-week treatment with AQX-1125, a loss of affect was observed, providing reassurance that there was a beneficial effect with AQX-1125. We believe this off-treatment finding in a short-duration trial is highly relevant and adds to our confidence in AQX-1125 as a promising drug, active at the 200 milligram dose.
Moving on to the secondary endpoints, in addition to the daily pain recorded in an e-diary, patients also reported pain to the study personnel at each clinic visit. Here on slide 9 you can see the average pain recorded at the clinic, which was found to be statistically significant for AQX-1125 at six weeks with a P value of 0.006. Again, pain improvement measured at the clinic showed loss of effect of AQX-1125 after patients completed treatment, shown here on slide 10.
On slide 11, another secondary endpoint examines the NRS pain data from the standpoint of maximum daily pain recorded by patients on their e-diary. On the diary, patients were asked to record what was their average pain during the day and what was the worst pain intensity, or maximum pain, they experienced each day. Again, you can see here on slide 11 the increasing reduction in patient reported maximum daily pain from AQX-1125 compared to placebo over time. Here, too, the comparison of maximum daily pain is statistically significant in favor of AQX-1125 after six weeks of treatment with a P value of 0.03.
On slide 12, as with the average daily pain scores, the treatment effect on maximum daily pain is also lost after treatment with AQX-1125 is completed. So whether we look at average or maximum daily pain recorded by the patient in their e-diary, or as reported to the study personnel at the clinic, the results all consistently favor AQX-1125 and the effect is lost consistently when treatment is completed.
Let us now move on to some of the secondary endpoints from the trial examining urological symptoms. On slide 14, a key leadership secondary endpoint was the O'Leary-Sant interstitial cystitis symptom index and problem index. The O'Leary-Sant ICSI/PI is a combined comprehensive measure of the symptoms patients suffer forming the symptom index and how much those symptoms inconvenience or bother them, the problem index. This questionnaire was developed specifically as an endpoint for BPS/IC trials and is used frequently in trials, as well as in clinical practice.
In LEADERSHIP, we asked patients to complete this questionnaire upon randomization for a baseline score, then again at the six-week visit at completion of treatment. The results are impressive with an improvement from baseline of 7.2 points for patients on AQX-1125 as compared to 2.8 points for placebo on a 36-point scale. This 4.4-point difference was highly statistically significant with a P value of 0.008.
A similarly comprehensive secondary endpoint from the leadership trial was the bladder pain interstitial cystitis symptom scale, or BPIC-SS, developed by Pfizer as a screening tool. Indeed, we did use the BPIC-SS during screening, requiring subjects to have a score of 19 or more both on visit one at screening and at visit two on randomization for them to be able to enter the treatment phase of the study.
Here, on slide 15, again we saw an encouraging effect of AQX-1125 with an 8.5-point reduction from baseline compared to 3.7-point reduction with placebo. The difference of 4.8 points on a 38-point scale at six weeks was statistically significant with a P value of 0.012.
An examination of bladder voiding frequency at week six showed no statistical difference between AQX-1125 and placebo, but there is an encouraging trend in favor of AQX-1125. As can be seen from the large standard error bars, voiding frequency is a highly variable endpoint. Consequently, we would need a larger trial to see a statistically significant change.
As well, women with BPS/IC have learned over years to keep their bladder empty as a way of reducing their pain. Thus, voiding frequency may have become a conditioned behavior that could take additional time for an improvement to be demonstrated.
So on slide 17, to summarize the primary and secondary efficacy endpoints we have analyzed to date, we believe the totality of the data provides a clear picture of the effects of AQX-1125 on pain and urinary symptoms. Both the primary and secondary endpoints are consistent. They follow a similar time course and a number of them are statistically significant at six weeks.
LEADERSHIP was powered solely for our primary endpoint, so to see such significant effects on our secondary endpoints we find very compelling. Further, this is a novel mechanism of action that is being studied on top of other therapies that patients were taking, making the results all the more impressive. As stated earlier by David, we firmly believe that AQX-1125 is a promising drug for BPS/IC and that the 200-milligram dose taken once daily is an active dose.
Now let's turn to the safety side. On slide 18 there is a summary of the safety and adverse event data taken from both our six-week LEADERSHIP trial and 12-week FLAGSHIP trial and they demonstrate AQX-1125 to be well tolerated with adverse event rates comparable to placebo.
For the combined studies, gastrointestinal effects were the most frequently reported adverse events for both AQX-1125 and placebo. GI events overall were slightly higher for AQX-1125, but led to no increased discontinuations, as can be seen in the bottom row on the table.
We have also reported that thus far we have seen no difference in the rate of ocular adverse events in humans with AQX-1125 compared to placebo. We monitor ocular events because from our preclinical toxicity studies we found the dose-limiting toxicity to be ocular changes in female rats. This toxicity in rats occurred at doses providing higher systemic exposure than the corresponding human clinical dose of 200 milligrams that we studied in both LEADERSHIP and FLAGSHIP.
Overall, the safety profile of AQX-1125 reinforces our confidence that 200 milligrams is well tolerated and suitable for chronic dosing.
Our final data slide, slide 19, we would like to share presents the pharmacokinetic results. We believe the state is particularly important and underscores why we chose BPS/IC as a high-priority clinical indication in our development program. At the 200-milligram dose in LEADERSHIP we achieved plasma concentrations of AQX-1125 very much as predicted and consistent with our prior studies.
The exciting new data is that urine concentrations of active drug also matched what we saw preclinically where we observed approximately 50% of AQX-1125 to be eliminated unmetabolized parent drug in the urine. Clearly our strategy of targeting an inflammatory condition of the bladder is well matched to both the mechanism of action and the buyer distribution profile for this drug.
As mentioned, we are still examining additional secondary efficacy endpoints from the LEADERSHIP trial, as well as conducting exploratory analyses in anticipation of presenting the full body of data at a future scientific meeting. More importantly, our team is actively compiling these results in anticipation of formal meetings with regulatory authorities including the FDA. These results provide us with the requisite valuable information to design pivotal trials for AQX-1125 in BPS/IC.
With that I will pass the call back to David to discuss the implications of these results in the context of Aquinox's overall clinical and corporate strategy. David?
David Main - President & CEO
Thank you, Steve. We believe that when the primary endpoint is viewed together with the secondary endpoint at six weeks, we see a consistent and strong picture of efficacy data for 1125. AQX-1125's biodistribution, ease of administration, and good safety profile thus far are well matched to this indication. These attributes reinforce our confidence that AQX-1125 has the potential competitive advantage and compares favorably with other oral drugs that have been studied or approved for BPS/IC.
We cannot lose sight of the tremendous unmet need for patients suffering from BPS/IC. We are determined to advance towards pivotal trials as soon as possible as the most valuable focus for the Company.
As Steve mentioned, we are in the process of preparing for discussions with the FDA and other regulatory bodies. We believe these results provide us valuable information that would allow us to design pivotal trials to support the ultimate registration of AQX-1125 for commercialization within this clinical indication.
With all the data presented today, I want to take a few minutes to review and remind you why we believe this is such an important market and valuable commercial opportunity for Aquinox. BPS/IC is a chronic inflammatory disease of the bladder characterized by pelvic pain and increased urinary urgency and/or frequency. BPS/IC has been properly recognized as a disease suffered by increasing numbers of women, but more recent reports suggest the disease may be both underreported and undiagnosed in men.
For many sufferers, symptoms of BPS/IC are severe and adversely affect all major aspects of their lives, including overall physical and emotional health, employment, social and intimate relationships, and leisure activities. Various scientific bodies, including the American Urological Association, the European Association of Urology, and the International Society for the Treatment of BPS, have all released guidance on this diseases documenting the seriousness of this condition and the challenge it poses to treatment.
There is no known cure for BPS/IC. We believe AQX-1125 has the potential to address the significant unmet need for a novel oral therapeutic that not only reduces symptoms, but also may modify the underlying disease process. And equally as important, being a therapy that will be easy and convenient for patients to take.
The prevalence of BPS/IC that ranges in different estimates from 5 million to 12 million people in the US is based in part on the largest prevalence study in IC ever conducted, namely the RAND IC Epidemiology Study. The prevalence of the disease is much larger than what is captured in either diagnosis or treatment reports. It is our belief, based upon commissioned research, that with no definitive diagnostic test and limited effective treatment the disease is both underreported and underdiagnosed.
There has been no new FDA-approved oral treatment of BPS/IC in the last 20 years. Most drugs are prescribed off-label and many available treatment regimens today are cumbersome, invasive, or only provide temporary benefit with a protracted time to onset of action. AQX-1125 is being developed and clinically investigated as a once-daily oral treatment. As Steve presented, pharmacokinetic evidence from LEADERSHIP supports this once-daily dosing regimen with an abundance of AQX-1125 arriving at the bladder from both the bloodstream and through the urine as it is being eliminated.
Turning to slide 23, our research combined with commissioned independent reports indicates that with an effective oral therapy, diagnosis and treatment rates are likely to increase, unlocking a largely untapped sizable market opportunity. To really bring this market opportunity into perspective, we only need to look at the current sales of Elmiron, the only oral drug approved for BPS/IC on the market today, and it was approved back in the 1990s.
This drug still commands a premium price of approximately $7,500 per year, but patient usage remains overall quite low because it requires taking three capsules per day, often takes up to six months to begin working, and published reports indicate that only a small percentage of patients actually receive any benefits. Additionally, in two Phase 4 confirmatory studies, Elmiron showed no benefit over placebo. Consequently, the compliance to the treatment regimen is low and many patients discontinue therapy shortly after starting.
Despite these significant limitations, Elmiron has gross annual sales nearing $280 million in the United States alone and is still growing at close to 10% per annum. The treatment figures shown on this slide likely underestimate the usage of drugs because many are used off-label, are generic, or are over-the-counter remedies. We believe BPS/IC sufferers ultimately take some form of oral therapy to try to relieve their pain and other symptoms, but there just isn't anything that is consistently effective.
With an effective oral, once-daily therapy our market research supports that diagnosis and recorded treatment rates should escalate, translating into a product opportunity that has the potential to be several multiples of Elmiron. Consequently, we believe the opportunity for AQX-1125 could exceed $1 billion in the United States alone.
Turning to slide 24, we want to highlight that we believe that AQX-1125 is a valuable asset and has the potential to support independent commercialization in the United States to maximize returns to our shareholders. A dire unmet medical need with an absence of any new meaningful therapy in decades has created an active and engaged BPS/IC community desperately seeking new options. This patient population is well-connected through support groups, advocacy networks, social media and online forums and are already proactively seeking new therapies.
In addition to an engaged patient population, BPS/IC is primarily treated by urologists and, to a lesser extent, by obstetricians and gynecologists. This landscape presents a highly-concentrated market for Aquinox to target with a specialty sales force. We know from independent research and existing product sales that the competitive landscape in BPS/IC is sparse and the threat of competition is limited, further increasing the attractiveness of this commercial opportunity.
In summary, we are confident that the combined data available to us thus far from LEADERSHIP presents a compelling efficacy and tolerability picture for AQX-1125 and a clearer product path forward for Aquinox. And to be quite honest, the timing of our data couldn't be better. September is IC awareness month. As highlighted on the Interstitial Cystitis Network's new campaign brochure, this is a disease from which millions suffer but few understand.
This is exactly how we see this market. It represents a sizable opportunity that few appreciate. We plan to change this perception through the development of AQX-1125, a product we believe has the necessary attributes to address this unmet medical need.
Of course, there's still work to do. Beyond planning pivotal trials, there's a lot of supportive activities that we are focused on. For example, in our clinical programs we have added for this year a bioequivalence clinical trial with our new tablet formulation of AQX-1125. We believe tablets are a preferred commercial product formulation, as they have the potential to speed manufacturing and lower cost of goods.
We have added this trial to generate the data that should allow us to use tablets for future pivotal trials and generate the supporting manufacturing documentation required for registration. As such, we have decided at this time not to initiate a Phase 2 trial in chronic sinusitis and instead accelerate our work to support the transition from capsules to tablets for 1125, as that is ultimately more important for registration.
As mentioned, raising awareness about BPS/IC is a key priority for us. Publishing results from LEADERSHIP at an upcoming scientific meeting is just one example. More relevant to you on the call today is our intent to hold a research day in New York in early October with our team and an independent key opinion leader in attendance. The purpose of this event will be to review the current state of BPS/IC, our LEADERSHIP full results, as well as discuss our proposed pivotal trial program.
The specific date and location has not yet been set, but we will communicate this as soon as that information is available. And of course, we hope that those of you in New York City can participate in person, while a webcast will be available for everyone else.
So let me conclude by simply stating we believe the results reported today support a compelling path forward for the Company for a drug that has the potential to help millions with a debilitating disease, with a potential market opportunity that may provide an attractive return on investment. We appreciate all of your time and attention today and we thank our shareholders for their continued support.
Now we would be happy to answer any questions.
Operator
(Operator Instructions) Ritu Baral, Cowen and Company.
Kevin Patel - Analyst
This is Kevin Patel speaking for Ritu Baral. With respect to BPS/IC, how does this data compare to the Elmiron data?
David Main - President & CEO
We always have to be cautious in making that comparison because, of course, this is not a randomized controlled trial comparing the two drugs. But from everything that we can see, we believe it compares very favorably. Probably what is most important about the data that has been reported about Elmiron is it's very contradictory. Really only the earliest studies showed benefit of Elmiron and fairly modestly over placebo and most of the subsequent trials have shown no advantage over placebo.
Again, I always want to be cautious. We haven't done that direct comparison, but we feel very confident that it is a very favorable comparison of the data we have generated in a very rigorous trial to that what has been reported for Elmiron.
Kevin Patel - Analyst
Okay, great.
David Main - President & CEO
Maybe I will just add one more thing, for the benefit of everybody listening. We don't necessarily see Elmiron as a competitor to AQX-1125. It's a very different mechanism of action.
It's a drug that is designed to help restore the lining of the bladder, so it's not inconceivable that the two drugs together could be quite beneficial, but what we really see from 1125 is that we can address the symptoms that the patients are suffering on a more acute basis. And then, over time, who knows how combined therapies could really benefit together?
Kevin Patel - Analyst
Okay, but just to be clear; the trials that you are looking for in the future are with solely AQX-1125, not AQX-1125 on top of Elmiron?
Stephen Shrewsbury - SVP, Clinical Development & Chief Medical Officer
Not necessarily. We will be looking obviously to have discussions with the FDA and with others. In LEADERSHIP a certain number of subjects were on Elmiron and we believe that AQX-1125 benefits patients whether they are on Elmiron or not. The exact inclusion/exclusion criteria and allowed concomitant medications in a future program will obviously be something that we will wish to discuss with the regulators.
David Main - President & CEO
But also, just to be clear on that, at this point we don't believe that we necessarily have to be on top of Elmiron. It's just one of the strategies that we would consider. We may consider straight trials of AQX-1125 versus placebo or add-on design. That's all part of the regulatory and market-planning strategy, but we do not believe the drugs have to be used together.
Kevin Patel - Analyst
Okay, thank you for taking my call and questions.
Operator
(Operator Instructions) Jeffrey Benison, Little Gem Life Sciences.
Jeffrey Benison - Analyst
I wanted to thank you for putting the call together. What I like about the data is all the secondary endpoints also, so it's not like you just came close on the primary but everything else is leading to show the benefit of the drug.
My question is, when looking at the size of the market, I know it's a different disease, but how big is overactive bladder? If people don't really know this ulcerative -- the data that -- the indication, but they know overactive bladder, and I was just wondering if that's a good comparison of what a good alternative of what an indication could be the size of the indication.
David Main - President & CEO
That's a great question. I don't think that we are prepared today to sort of compare them head-to-head and say numbers versus numbers, but what we know from talking to key opinion leaders is that they believe that interstitial cystitis is a much more troubling condition that is more desperate in need of treatment and that has a much more profound effect on patients' lives. So when we look at what we've seen reported this is considered right now by the urology community as one of the greatest and more troubling diseases that needs to be tackled.
Jeffrey Benison - Analyst
When you're looking commercially and saying it's a specialized group of doctors, that would be maybe what you could do. But maybe you would have the potential to partner for the more -- to the primary care physicians. You wouldn't be looking for those, but that might be a partnership opportunity for you when you get more data.
David Main - President & CEO
Absolutely. We think that we can tackle the most important parts of the market through a specialty salesforce. We do not have any intention to build a primary care organization, but I feel that that is an upside opportunity for us to consider long term. How we consider with other organizations that do have primary care organizations that we could enter into some sort of co-promotion to tackle a larger market.
What we know from our primary market research is that treatment and diagnosis starts with the specialty group. It's really the maintenance therapy that moves into primary care, so the important place to start is in the specialty market.
Jeffrey Benison - Analyst
Right, okay. Thank you very much.
Operator
Ritu Baral, Cowen and Company.
Kevin Patel - Analyst
Sorry, that was by accident.
Operator
[Michael Thompson].
Michael Thompson - Analyst
Yes, I had a quick question about sort of one of the points that came up in terms of you mentioned I think greater than 50% of the parent compound was excreted via the urine unmetabolized. And I guess I just wanted to know do you attribute at least some of the efficacy to the fact that the drug was sitting in the bladder and somehow was activating the SHIP1 molecule?
Stephen Shrewsbury - SVP, Clinical Development & Chief Medical Officer
Yes, very much. We believe that contributed to its efficacy in this study, and as you point out, the drug does get into the urine in considerably larger concentration than actually seen in the bloodstream. And that was really our expectation from the preclinical data where we found about 50% of the drug was eliminated unmetabolized in the urine, and that was a major factor in us deciding to study this particularly difficult condition as one of our Phase 2 studies.
Operator
Thank you, sir. There are no further questions at this time. I would like to turn the call over to management for any closing remarks.
Brendan Payne - Senior Manager, IR
On behalf of Aquinox, I would just like to thank everyone for participating and invite you to contact us if you have any questions. Thank you again.
Operator
Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Have a wonderful day.