Aquinox Announces Topline Results of Phase 3 LEADERSHIP 301 Clinical Trial in Interstitial Cystitis/Bladder Pain Syndrome

VANCOUVER, Canada I June 27, 2018 I Aquinox Pharmaceuticals, Inc. (“Aquinox“) (NASDAQ:AQXP), today announced that the Phase 3 LEADERSHIP 301 clinical trial evaluating once-daily, oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet its primary endpoint.

“This is a disappointing result for Aquinox and for patients,” said David Main, President and CEO of Aquinox. “LEADERSHIP 301 was a robust and well-conducted trial, and we believe the results are definitive. We have conducted a number of sensitivity, subpopulation, and secondary endpoint analyses and none demonstrate a benefit of rosiptor over placebo. We had hoped to deliver better news to the patients and investigators that made the personal commitment to participate in the trial.”

Main added, “These results support halting all further development activities with rosiptor. We will be undertaking a thorough evaluation of our pipeline and other strategic options available to the company and will be in a position to provide further guidance later this year.”

LEADERSHIP 301 enrolled 433 participants, including 341 female subjects who were randomized to receive rosiptor 100 mg or 200 mg, or placebo. The trial was balanced in terms of baseline characteristics between arms, and enrolled a population very similar to the prior Phase 2 trial. Rosiptor failed to achieve a statistically significant reduction in the mean change from Baseline at Week 12 in maximum daily bladder pain score compared to placebo (P=0.41) in the female subjects, which was the primary endpoint. 

Rosiptor was generally well tolerated with the rate of adverse events during the 12-week treatment period similar to that of placebo and prior trials.

Aquinox will host a conference call later today for investors regarding this announcement with details as follows:

About the LEADERSHIP 301 Trial
The LEADERSHIP 301 trial was a three-arm, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial assessing the effect of once-daily rosiptor (AQX-1125) on bladder pain and urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS). Subjects were enrolled at leading clinical research centers in the United States, Canada, and Europe.

About Interstitial Cystitis/Bladder Pain Syndrome
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating condition marked by chronic bladder pain and urinary symptoms. Patients may experience recurring pain, pressure, and/or discomfort perceived to be related to the urinary bladder as well as urinary frequency, urgency, and/or nocturia. The pain often worsens upon bladder filling and may be relieved upon bladder emptying. Many patients living with IC/BPS report that it takes a physical, emotional, and psychological toll, greatly impacting employment and social and intimate relationships. There are currently few FDA approved and/or effective treatment options for IC/BPS. Only about 1M of the 5.5M adults in the United States with symptoms of IC/BPS have been diagnosed or are receiving treatment.

About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a pharmaceutical company developing novel therapeutics for conditions marked by inflammation, inflammatory pain, and blood cancers. For more information, please visit www.aqxpharma.com.