Vistagen Announces Completion of Last Patient, Last Visit in Phase 2 Clinical Trial of PH94B for the Treatment of Adjustment Disorder with Anxiety
January 10 2023 - 8:30AM
Business Wire
Topline results of the exploratory Phase 2
clinical study anticipated in Q1 2023
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression, and other central nervous system
(CNS) disorders, today announced that the last patient has
completed the study protocol in its Phase 2 clinical trial of PH94B
for the treatment of adults experiencing adjustment disorder with
anxiety (AjDA).
The exploratory Phase 2 clinical trial is a U.S. multi-center,
randomized, double-blind, placebo-controlled study intended to
evaluate efficacy, safety and tolerability of PH94B administered
four times per day over four weeks for the treatment adjustment
disorder with anxiety symptoms in adults. The primary endpoint is
the change from baseline in anxiety level as measured by the
Hamilton Anxiety Rating Scale (HAM-A) at the end of Week 4 of
treatment with PH94B or placebo. Dr. Michael Liebowitz, a former
Columbia University psychiatrist, founder of the Anxiety Disorders
Clinic at the New York State Psychiatric Institute, and currently
director of the Medical Research Network in New York City, is
serving as Principal Investigator of the trial. Topline results are
anticipated at the end of Q1 2023.
“The four-week treatment protocol for our final enrolled patient
is complete. This is a major milestone for our team,” stated Shawn
Singh, Chief Executive Officer of Vistagen. “Along with many other
mental health challenges, the prevalence of adjustment disorder is
alarming due to increasing levels of health, safety, economic and
social stressors that adversely impact mental health and wellbeing.
Vistagen is dedicated to developing treatments to address the
escalating mental health crisis. We look forward to completing data
analysis for this important study over the coming months.”
About PH94B
Vistagen’s PH94B is a first-in-class, rapid-onset
investigational pherine nasal spray with a novel proposed mechanism
of action (MOA) that regulates the olfactory-amygdala neural
circuits of fear and anxiety and attenuates the tone of the
sympathetic autonomic nervous system, without systemic
distribution, potentiation of GABA-A or direct activity on CNS
neurons in the brain. Vistagen is developing PH94B in a Phase 3
program for the treatment of social anxiety disorder and in an
exploratory Phase 2 development program for the treatment of
adjustment disorder with anxiety. Designed for intranasal
administration in low microgram doses, the proposed novel MOA of
PH94B is fundamentally differentiated from all currently approved
anti-anxiety medications, including all antidepressants and
benzodiazepines.
About Adjustment Disorder
Adjustment disorder (AjD) refers to a maladaptive emotional or
behavioral response to an identifiable stressor. AjD occurs within
three months of exposure to the stressor as evidenced by marked
distress that is out of proportion to the socially or culturally
expected reactions to the stressor, or that represents significant
impairment in social, occupational or other important areas of
daily functioning. A Mental Health Surveillance Study estimated
prevalence of adjustment disorder at 7% in the U.S. adult
population, or about 18 million adults in the U.S, in 2022. Current
pharmacological treatments for AjD vary widely. Current treatments
include antidepressants, benzodiazepines and buspirone, among
others.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available.
Vistagen’s clinical-stage candidates are targeting multiple forms
of anxiety and depression. PH94B and PH10 belong to a new class of
drugs known as pherines, which are investigational neuroactive
steroid nasal sprays designed with a novel rapid-onset mechanism of
action that activates chemosensory neurons in the nasal passages
and can impact the olfactory-amygdala neural circuits without
systemic uptake or direct activity on CNS neurons in the brain.
Vistagen is passionate about transforming mental health care and
redefining what is possible in the treatment of anxiety and
depression. Connect at www.Vistagen.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by Vistagen and its management,
are inherently uncertain. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Among other things, there can
be no guarantee that any of the Company’s drug candidates,
including PH94B and/or PH10, or any other pherine drug candidate
will successfully complete ongoing or future clinical trials,
receive regulatory approval or be commercially successful. These
risks, along with additional risks, are more fully discussed in the
section entitled "Risk Factors" in the Company’s most recent Annual
Report on Form 10-K for the fiscal year ended March 31, 2022 and in
the Company’s most recent Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022, as well as discussions of
potential risks, uncertainties, and other important factors in our
other filings with the U.S. Securities and Exchange Commission
(SEC). The Company’s SEC filings are available on the SEC’s website
at www.sec.gov. You should not place undue reliance on these
forward-looking statements, which apply only as of the date of this
press release and should not be relied upon as representing the
Company’s views as of any subsequent date. The Company explicitly
disclaims any obligation to update any forward-looking statements,
other than as may be required by law. If the Company does update
one or more forward-looking statements, no inference should be made
that the Company will make additional updates with respect to those
or other forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230110005496/en/
Investors Mark Flather Vice President, Investor Relations
(650) 577-3617 mflather@vistagen.com
Media Nate Hitchings SKDK nhitchings@skdknick.com
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