Vistagen Advances Intellectual Property Program to Expand Patent Protection for PH94B to Include Treatment of Adjustment Disorder
December 30 2022 - 8:30AM
Business Wire
Vistagen’s recent patent filings in the U.S.
and numerous additional countries mark the next step in the
Company’s ongoing efforts to enhance potential commercial
protection across its CNS pipeline in key pharmaceutical
markets
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 Company has taken
important strategic steps to secure additional patent protection
for its lead product candidate, PH94B, through the recent filing of
national applications at the U.S. Patent and Trademark Office
(USPTO) and counterpart patent authorities in major pharmaceutical
markets outside the U.S. for the treatment of adjustment disorder
(AjD).
These new filings are intended to provide a global exclusivity
platform for PH94B in AjD, similar to the Company’s patent
protection for PH94B for the treatment of social anxiety disorder
(SAD), and for its other late-clinical stage product candidate,
PH10, for the treatment of major depressive disorder (MDD).
Vistagen recently announced its pending acquisition of Pherin
Pharmaceuticals, Inc. Upon closing of the acquisition, which is
subject to certain customary closing conditions, Vistagen will
acquire Pherin’s entire pherine pipeline, resulting in Vistagen
gaining full ownership of intellectual property rights to PH94B,
which is currently in Phase 3 development for SAD and Phase 2
development for AjD with anxiety (AjDA), and PH10, which is in
clinical development for MDD. Vistagen will also gain full
ownership of three new early clinical-stage pherine product
candidates: PH15 for cognition improvement; PH284 for
appetite-related disorders and PH80 for migraine and hot flashes.
When the acquisition is completed, Vistagen's global patent
portfolio for novel pherine class compounds will further expand to
include U.S. and foreign counterpart patent applications related to
the use of PH80 for the treatment of migraine and for the treatment
of hot flashes.
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 types
of anxiety and depression. PH94B and PH10 belong to a new class of
drugs known as pherines, which are odorless and tasteless
investigational neuroactive steroids 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.
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. Current pharmacological treatments for AjD vary
widely and include antidepressants, benzodiazepines, buspirone and
natural products such as cannabidiol. Vistagen’s ongoing
exploratory Phase 2A clinical program for PH94B in AjD is focused
on adults experiencing AjD with anxiety (AjDA). The randomized,
double-blind, placebo-controlled study in AjDA in adults involves
daily use of PH94B administered four times per day in a real-world
outpatient setting for 28 days. Vistagen expects top line results
from the study in Q1 2023.
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: the Company will secure additional patent
protection or any other form of commercial protection for PH94B,
including for the treatment of adjustment disorder, or any of the
Company’s other drug candidates; any of the Company’s drug
candidates, including PH94B and/or PH10, or any other drug
candidate will successfully complete ongoing or future clinical
trials, receive regulatory approval or be commercially successful;
the Company and Pherin will successfully satisfy the closing
conditions set forth in their merger agreement, including approval
of the proposed acquisition by Pherin’s stockholders; Vistagen’s
ability to realize the anticipated benefits of the proposed
acquisition of Pherin, including the possibility that the expected
benefits will not be realized or will not be realized within the
expected time period; or unknown liabilities of Pherin that may or
may not be within Vistagen’s control. Certain of these 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/20221230005022/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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