Aquinox Statement on FDA Advisory Committee Meeting to Discuss Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
December 07 2017 - 7:25PM
- Bone, Reproductive, and Urologic Drugs
Advisory Committee Votes Unanimously in Favor of Unified IC/BPS
Population for Clinical Trials -
Aquinox Pharmaceuticals, Inc. ("Aquinox") (NASDAQ:AQXP), a
clinical-stage pharmaceutical company discovering and developing
targeted therapeutics in disease areas of inflammation and
immuno-oncology, today issued the following statements following
the U.S. Food and Drug Administration (FDA) Bone,
Reproductive, and Urologic Drugs Advisory Committee meeting on
interstitial cystitis/bladder pain syndrome (IC/BPS).
At the meeting, the panel voted 15 to 0 that patients with
interstitial cystitis and patients with bladder pain syndrome
should be combined in clinical trials. This is aligned with the
current American Urological Association (AUA) guideline and
Aquinox’s position that IC/BPS is a single symptom complex defined
by bladder pain and urinary symptoms.
The following statement may be attributed to Aquinox President
& CEO David Main:
“We greatly appreciate the FDA’s interest in this
chronic, often debilitating condition and the Agency’s commitment
to helping accelerate the development of new and effective
treatment options, which are desperately needed for patients
suffering from IC/BPS. The Committee’s vote is aligned with the
approach we have taken in Aquinox’s clinical development program
for rosiptor (AQX-1125). We look forward to additional interaction
with the Agency based on today’s discussion as we advance our
program.”
The following statement may be attributed to Aquinox Chief
Medical Officer Barbara Troupin, MD, MBA:
“An estimated 5.5 million adults in the US suffer from symptoms
consistent with IC/BPS, yet only about a million have been
diagnosed or are receiving treatment – evidence of the clear and
pressing need for new, effective, and well-tolerated therapies. We
appreciate the patients with IC/BPS who shared their experiences
today, illustrating the profound impact the condition has on their
social, emotional, and overall quality of life. Aquinox is
committed to developing its lead drug candidate rosiptor for the
treatment of bladder pain and urinary symptoms associated with
IC/BPS, to address the unmet need and relieve these patients’
symptoms.”
The advisory committee meeting took place at the FDA’s
White Oak Campus in Silver Spring, MD.
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 TrialThe
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 is 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
StatementsCertain of the statements made in this press
release are forward looking, such as those, among others, relating
to: development of rosiptor (AQX-1125), LEADERSHIP 301 and
availability of top-line data. 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 (AQX-1125) or any future product candidates and our
ability to serve those markets; our ability to obtain and maintain
regulatory approval of rosiptor (AQX-1125) 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 September 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.
Contact Info:
Investors:Brendan
PayneAssociate Director, Investor Relations
Aquinox Pharmaceuticals,
Inc.604.901.3019ir@aqxpharma.com
Media:Lisa
GuitermanOrangefieryOffice: 301-217-9353Mobile:
202-330-3431lisag@orangefiery.com
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