Aquinox Announces Topline Results of Phase 3 LEADERSHIP 301 Clinical Trial in Interstitial Cystitis/Bladder Pain Syndrome
June 27 2018 - 6:30AM
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:
Conference Call and Webcast Details:Date: June
27, 2018Time: 8:30 AM EDT, 5:30 AM PDTToll-free:
1-866-357-7878International: 1-315-625-3088Audience Passcode
9289537Webcast URL: https://edge.media-server.com/m6/p/n9fonzcy
The archived webcast will also be available on Aquinox's website
at www.aqxpharma.com approximately two hours after the event
and will be available for replay for at least 30 days after the
event.
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
SyndromeInterstitial 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.
Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, including those relating to evaluation of our pipeline and
strategic options. These statements are subject to risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated, including, but not limited to,
risks and uncertainties related to: clinical drug development is a
lengthy and expensive process with an uncertain outcome; our
ability to identify or acquire additional clinical candidates, our
ability obtain and maintain regulatory approval for any future
product candidates and the potential safety, efficacy or clinical
utility of or any future product candidates. Actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. More information about the
risks and uncertainties faced by Aquinox is contained in the
company’s Annual Report on Form 10-K for the year
ended December 31, 2017, and subsequent reports, filed with
the Securities and Exchange Commission. Aquinox disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor
Contact: |
Media
Contact: |
|
|
Brendan
Payne |
Dan Boyle |
Associate Director,
Investor Relations |
Orangefiery |
Aquinox
Pharmaceuticals, Inc. |
818.209.1692 |
604.901.3019 |
dan@orangefiery.com |
ir@aqxpharma.com |
|
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