Vistagen to Proceed with PALISADE-2 Phase 3 Clinical Trial of PH94B in Social Anxiety Disorder following Interim Analysis
September 08 2022 - 8:00AM
Business Wire
Independent biostatisticians recommend
continuing PALISADE-2 without any changes after conducting interim
analysis of 140 completed subjects
Topline data for PALISADE-2 trial expected in
the first half of 2023
Vistagen Therapeutics, Inc. (Nasdaq: VTGN) (Vistagen, the
Company), 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 the completion of an interim analysis of
PALISADE-2, the Company’s second Phase 3 clinical trial assessing
drug candidate PH94B as an acute treatment of anxiety in adults
with Social Anxiety Disorder (SAD), which concluded that PALISADE-2
should continue as planned.
Independent biostatisticians reviewed unblinded data from the
140 subjects who completed PALISADE-2 before the Company paused
enrollment in the study in July 2022, following announcement of
topline results from PALISADE-1, its first Phase 3 clinical trial
of PH94B in SAD. Although the Company does not itself have access
to unblinded data from PALISADE-2, based on the outcome of the
interim analysis and the recommendation of the independent
biostatisticians, Vistagen will continue PALISADE-2 as planned to
the full enrollment of 208 subjects, without any adjustment to the
size of the study. Vistagen expects topline results from PALISADE-2
in the first half of 2023.
“We are encouraged by the recommendation to continue PALISADE-2
to full enrollment as originally planned,” said Shawn Singh, Chief
Executive Officer of Vistagen. “Following the results of
PALISADE-1, we had independent biostatisticians conduct the interim
analysis to gain insight on the best course of action for
PALISADE-2, including possibly expanding the number of subjects in
the study, significantly amending the study protocol or halting the
study altogether. We believe that the recommendation resulting from
the interim analysis to resume PALISADE-2 is the best course of
action. While we further evaluate the results of PALISADE-1,
building on both the continuation of PALISADE-2 and preliminary
data from our open label safety study of PH94B, we are also
preparing to meet with the FDA later this year to discuss our plans
for further Phase 3 development of PH94B in Social Anxiety
Disorder.”
PH94B is an innovative, fast-acting, odorless pherine
administered intranasally at microgram doses. It is currently in
clinical trials to treat multiple anxiety disorders without the
side effects and safety concerns associated with currently
prescribed and off-label medications. PH94B demonstrated
tolerability in PALISADE-1 that was consistent with reported
results from previous clinical trials. No severe or serious adverse
events were reported for PH94B in PALISADE-1 or PALISADE-2 or in
other clinical trials.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused
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. PH94B and
PH10 belong to a new class of drugs known as pherines, which are
odorless and tasteless 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 any pharmaceutical product, 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’s PALISADE-2 Phase 3 clinical
trial will be successful or that PH94B or any of the Company’s
other drug candidates will receive regulatory approval or be
commercially successful. Other factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to resuming and completing the Company’s PALISADE-2 Phase
3 clinical trial; the effect, if any, of the previously announced
topline results of the Company’s PALISADE-1 Phase 3 clinical trial;
the completion and results of the Company’s ongoing clinical
studies of PH94B, including the Company’s Phase 2A clinical trial
of PH94B in adults experiencing adjustment disorder with anxiety;
delays in launching, conducting and/or completing other ongoing and
planned clinical trials, including delays due to the impact of the
ongoing COVID-19 pandemic; fluctuating costs of materials and other
resources required to conduct the Company’s ongoing and/or planned
clinical and non-clinical trials; market conditions; the impact of
general economic, industry or political conditions in the United
States or internationally; and other technical and unexpected
hurdles in the development, manufacture and commercialization of
the Company’s CNS drug candidates. These risks are 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 June 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/20220908005443/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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