Aquinox Offers Added Exploratory Analyses from LEADERSHIP Phase 2 Trial in Patients with BPS/IC at ESSIC

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Aquinox Pharmaceuticals, Inc. ("Aquinox")
AQXP
, a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, today presented additional exploratory analyses from its LEADERSHIP Phase 2 clinical trial in patients with bladder pain syndrome/interstitial cystitis (BPS/IC) at the 2015 International Society for the Study of BPS (ESSIC) Conference taking place in Rome, Italy. Pre-specified primary and secondary endpoint results from the LEADERSHIP trial were reported on June 25, 2015 and August 6, 2015, respectively. Additional LEADERSHIP data presented today included exploratory analyses of responder rates for average daily pain and maximum daily pain. Evaluating patients that achieved at least a 30% and 50% reduction in their pain demonstrated that AQX-1125 approximately doubled the response rate compared to those patients that received placebo for both average and maximum daily pain. Further analyses also revealed that the two components of the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and the Problem Index (ICPI) each individually demonstrated a statistically significant improvement in favor of AQX-1125 compared to placebo. "It is reassuring to see that these additional analyses consistently support the benefit of AQX-1125 observed in the primary and secondary endpoint results already reported," said Dr. Stephen Shrewsbury, CMO and Senior VP of Clinical Development. "We are pleased to present these encouraging results to the BPS/IC community attending ESSIC and we look forward to discussing these results with regulators, including the FDA, and the wider urology community as we advance towards pivotal trials." Data presented at ESSIC also included baseline demographic information demonstrating the trial to be well balanced between AQX-1125 and placebo groups in terms of age, duration of diagnosis, concomitant medications and baseline scores for both pain (11-point NRS) and urological symptoms (O'Leary-Sant ICSI/PI & BPIC-SS). On the 11-point NRS scale, mean baseline scores for average daily pain on entry were 6.4 for patients randomized to AQX-1125 and 6.7 for placebo recipients. Mean baseline scores for maximum daily pain on entry were 7.6 for patients randomized to AQX-1125 and 7.9 for patients given placebo. On the combined 36-point O'Leary-Sant indices, mean baseline scores were 27.3 for patients randomized to AQX-1125 and 30.2 for patients given placebo and on the 38-point BPIC-SS mean baseline scores on entry were 29.6 for AQX-1125 and 31.6 for placebo. A majority of patients in both arms (~64%) were on background medications, including approximately 30% on Elmiron, for treatment of their BPS/IC. The results from LEADERSHIP are particularly compelling given that the baseline demographics represent a predominantly severe BPS/IC patient population, a majority of which were on background medications and yet still experiencing moderate to severe symptoms at study entry. The benefit from AQX-1125 compared to placebo is notable as patients in both groups were allowed to remain on most forms of background medications throughout the LEADERSHIP trial. The podium presentation from the ESSIC conference is available on the "Meetings & Conferences" page of Aquinox's website at: http://aqxpharma.com/content/scientific-clinical-meetings-conferences and the abstract from the conference can be found on the "Selected Publications" page at: http://aqxpharma.com/content/selected-publications.
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