EASTWOOD, Australia,
Jan. 3, 2022 /PRNewswire/ --
Bionomics Limited (ASX: BNO, NASDAQ: BNOX) (Bionomics or
Company), a clinical-stage biopharmaceutical company, is
pleased to announce that it has initiated its Phase 2 clinical
trial (the PREVAIL Study) to evaluate BNC210 for the acute
treatment of Social Anxiety Disorder (SAD), with topline results
expected by the end of 2022.
BNC210 is an oral, proprietary, selective negative allosteric
modulator of the α7 nicotinic acetylcholine receptor in development
for the acute treatment of SAD and chronic treatment of
Post-Traumatic Stress Disorder (PTSD), with U.S. Food and Drug
Administration (FDA) Fast Track designation for both clinical
indications.
The PREVAIL Study SAD protocol was cleared by the FDA in
November 2021, and it was granted
ethics approval by a central U.S. Institutional Review Board (IRB)
in December 2021. With these
approvals in place, as well as site-level approvals, clinical sites
in the U.S. are now activated and open to screening for potential
study participants aged 18 to 65 years old with marked to severe
SAD. Study participants will need to have a score of at least 70 on
the Liebowitz Social Anxiety Scale, which is a scale that assesses
a patient's reported level of social phobia in a range of social
and performance situations. It is anticipated that 15 to 20
clinical sites in the U.S. will be involved in recruiting patients
for this study.
In this randomised, double-blind, placebo-controlled trial,
BNC210 will be evaluated as an acute, or single-dose, treatment for
patients with SAD. Study participants will be randomly assigned to
one of three treatment groups, 225 mg BNC210, 675 mg BNC210 or
placebo, with approximately 50 participants in each group. They
will be orally administered a single dose of their assigned
treatment approximately one hour prior to taking part in an
anxiety-provoking behavioral task involving a speaking challenge.
The primary objective of the study is to compare each dose level of
BNC210 to placebo on self-reported anxiety levels using the
Subjective Units of Distress Scale (SUDS). Secondary objectives
include two other scales measuring participants' anxiety levels
(State-Trait Anxiety Inventory and Self-Statements During Public
Speaking), as well as an evaluation of the safety and tolerability
of BNC210 in this population.
"Anxiety disorders are a significant burden for our communities
and approximately 18 million adults suffer from Social Anxiety
Disorder in the United States
alone. Patients will typically experience persistent and intense
fear of social or performance-related situations when exposed to
unfamiliar people or to possible scrutiny by others. They will
often engage in avoidance behaviours to manage their fears, which
can interfere with functioning, increase loneliness and social
isolation, and diminish quality of life. There is a great unmet
need for fast-acting, as-needed treatments for these patients
because the only FDA approved medications for Social Anxiety
Disorder take several weeks or longer before they impact symptoms.
Safe and effective on-demand treatments could help people with
Social Anxiety Disorder engage with, rather than avoid,
anxiety-provoking situations when they need to the most." said
Bionomics' consultants at University of
California (San Diego) Drs. Charles
Taylor (Associate Professor, Department of Psychiatry) and
Murray Stein (Distinguished
Professor, Department of Psychiatry).
"The new tablet formulation of BNC210, which is rapidly absorbed
and reaches maximal concentrations in the blood in approximately
one hour, is being evaluated in the PREVAIL study as an oral
as-needed treatment for SAD patients to better cope with
anticipated anxiety-provoking social interactions and other public
settings. We look forward to taking advantage of the Fast Track
designations for both SAD and PTSD treatment indications, and our
goal is to report topline data in late 2022 for the PREVAIL Study
and by the middle of 2023 for the ongoing Phase 2b PTSD ATTUNE Study." said Bionomics' Executive
Chairman, Dr. Errol De Souza.
Released on authority of the Executive Chairman.
About Bionomics Limited
Bionomics (ASX: BNO, NASDAQ:
BNOX) is a clinical-stage biopharmaceutical company developing
novel, allosteric ion channel modulators designed to transform the
lives of patients suffering from serious central nervous system
("CNS") disorders with high unmet medical need. Bionomics is
advancing its lead product candidate, BNC210, an oral, proprietary,
selective negative allosteric modulator of the α7 nicotinic
acetylcholine receptor, for the acute treatment of Social Anxiety
Disorder ("SAD") and chronic treatment of Post-Traumatic Stress
Disorder ("PTSD"). Beyond BNC210, Bionomics has a strategic
partnership with Merck & Co., Inc (known as MSD outside
the United States and Canada) with two drugs in early-stage clinical
trials for the treatment of cognitive deficits in Alzheimer's
disease and other central nervous system conditions.
www.bionomics.com.au
Factors Affecting Future Performance
This
announcement contains "forward-looking" statements within the
meaning of the United States'
Private Securities Litigation Reform Act of 1995. Any statements
contained in this announcement that relate to prospective events or
developments, including, without limitation, statements made
regarding Bionomics' drug candidates (including BNC210), drug
discovery programs, ongoing and future clinical trials, and timing
of the receipt of clinical data for our drug candidates are deemed
to be forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "projects," "forecasts," "will"
and similar expressions are intended to identify forward-looking
statements. There are a number of important factors that could
cause actual results or events to differ materially from those
indicated by these forward-looking statements, including unexpected
safety or efficacy data, unexpected side effects observed in
clinical trials, risks related to our available funds or existing
funding arrangements, our failure to introduce new drug candidates
or obtain regulatory approvals in a timely manner or at all,
regulatory changes, inability to protect our intellectual property,
risks related to our international operations, as well as other
factors. Results of studies performed on our drug candidates and
competitors' drugs and drug candidates may vary from those reported
when tested in different settings.
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SOURCE Bionomics Limited