Aquinox Statement on FDA Advisory Committee Meeting to Discuss Interstitial Cystitis/Bladder Pain Syndrome
August 28 2017 - 9:15AM
- Meeting to be Held December 7, 2017
-
Aquinox Pharmaceuticals, Inc. (“Aquinox”) (NASDAQ:AQXP), a
clinical-stage pharmaceutical company discovering and developing
targeted therapeutics in disease areas of inflammation and
immuno-oncology issued today the following statement regarding the
announcement by the United States Food and Drug Administration
(FDA) Division of Bone, Reproductive and Urology Products (DBRUP)
that it will hold an Advisory Committee meeting to discuss
Interstitial Cystitis and Bladder Pain Syndrome (IC/BPS).
“The FDA had indicated to us previously and confidentially the
possibility of this meeting and we welcome the opportunity of a
public forum, with input from patients, clinicians, regulators and
sponsors, to incorporate current thinking around therapeutic
development in IC/BPS,” said David Main, President & CEO of
Aquinox. “With the diagnosis and treatment of IC/BPS having evolved
since the last oral drug for IC/BPS was approved in the US more
than 20 years ago, we regard this meeting as recognition of the
persisting high unmet need for new, effective therapies and of the
debilitating impact of this disease on millions of patients. We
believe the meeting will add important context in advance of our
reporting of results from our LEADERSHIP 301 trial and greater
clarity for the design of future clinical trials with rosiptor in
IC/BPS.”
The advisory committee meeting is scheduled to be held December
7, 2017 from 8:00 AM to 5:00 PM EST at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD. Notice of the meeting and a
proposed agenda can be found on the Federal Register at
https://federalregister.gov/d/2017-18131.
About Rosiptor (AQX-1125)
Rosiptor, Aquinox's lead drug candidate, is a small molecule
activator of SHIP1, which is a regulating component of the PI3K
cellular signaling pathway. By increasing SHIP1 activity, rosiptor
accelerates a natural mechanism that has evolved to maintain
homeostasis of the immune system and reduce immune cell activation
and migration to sites of inflammation. Rosiptor has demonstrated
preliminary safety and favorable drug properties for once daily
oral administration in multiple preclinical studies and eight
completed clinical trials.
About Interstitial Cystitis/Bladder Pain Syndrome
(IC/BPS)
IC/BPS is a chronic inflammatory bladder disease characterized
by pelvic pain and increased urinary frequency and/or urgency. For
many sufferers, these symptoms 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. While the cause of the disease remains
largely unknown, erosion of the bladder lining is thought to be a
significant contributor. IC/BPS is estimated to affect millions of
people in the United States and around the world. Most
IC/BPS patients continue to suffer this debilitating condition,
despite treatment with existing therapies. Most current therapies
and those in development are focused solely on symptomatic relief
of IC/BPS. Aquinox believes new and innovative therapies that
target the underlying disease to reduce the chronic pain and
urinary symptoms are needed.
About the LEADERSHIP
301 Trial
The LEADERSHIP 301 trial, which commenced enrollment in
September 2016, is a three-arm, multicenter, randomized,
double-blind, placebo-controlled Phase 3 clinical trial
investigating the ability of 200 mg and 100 mg oral, once daily
rosiptor (AQX-1125) to reduce bladder pain in patients with IC/BPS.
The primary endpoint of the LEADERSHIP 301 trial is the difference
in the change from baseline in the maximum daily bladder pain score
based on an 11-point numeric rating scale (NRS) at twelve weeks
recorded by electronic diary. Additional endpoints include urinary
symptoms, including frequency and nighttime awakenings to void, as
well as measures of quality of life. The LEADERSHIP 301 trial also
has an additional 52-week extension period, affording all
participating patients the opportunity for treatment with rosiptor.
An anticipated minimum of 300 female patients, up to a maximum of
600 patients including males, are currently being enrolled at
clinical research centers in the United States, Canada and Europe.
Top-line data from the LEADERSHIP 301 trial are anticipated in
third quarter of 2018.
About Aquinox
Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a late clinical-stage
pharmaceutical company discovering and developing targeted
therapeutics in disease areas of inflammation and immuno-oncology.
Our primary focus is anti-inflammatory product candidates
targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1,
which is a key regulator of an important cellular signaling pathway
in immune cells, known as the PI3K pathway. Aquinox's lead drug
candidate, rosiptor (AQX-1125), is a small molecule activator of
SHIP1 suitable for oral, once daily dosing. In September
2016, we began enrolling patients in a Phase 3 clinical trial of
rosiptor in our lead indication, Interstitial Cystitis/Bladder Pain
Syndrome (IC/BPS). Other indications are under consideration
for future investigation. Aquinox has a broad intellectual property
portfolio and pipeline of preclinical drug candidates that activate
SHIP1. 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, such as those, among others, relating to: the scheduled
DBRUP Advisory Committee meeting to discuss IC/BPS, development of
rosiptor (AQX-1125), LEADERSHIP 301, availability of top-line data,
and initiation of clinical trials. 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: our ability to
enroll patients in our clinical trials at the pace that we project;
as an organization, we have never conducted a pivotal clinical
trial before; the size and growth of the potential markets for
rosiptor or any future product candidates and our ability to serve
those markets; our ability to obtain and maintain regulatory
approval of rosiptor or any future product candidates; reaching
agreement on design of pivotal trials with regulatory authorities
and our expectations regarding the potential safety, efficacy or
clinical utility of rosiptor 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 Quarterly Report on Form 10-Q for the
quarter ended June 30, 2017 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 Info:
Brendan PayneAssociate Director, Investor
Relations Aquinox Pharmaceuticals,
Inc.604.901.3019ir@aqxpharma.com
Gitanjali Ogawa Vice President The Trout
Group646-378-2949Gogawa@troutgroup.com
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