Vistagen Announces Completion of Last Patient, Last Visit in Phase 1 Clinical Trial of Itruvone (PH10), an Investigational Pherine Nasal Spray for Major Depressive Disorder
March 08 2023 - 8:30AM
Business Wire
U.S. Phase 1 study with newly optimized
formulation intended to facilitate Phase 2B development of itruvone
as a stand-alone treatment of major depressive disorder
Top line results anticipated in Q2 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 participant has
completed the study protocol in its U.S. Phase 1 clinical trial of
itruvone (PH10), the Company’s investigational pherine nasal spray
for the treatment of major depressive disorder (MDD).
The primary objective of this U.S. single-center, randomized,
double-blind, placebo-controlled Phase 1 study is to investigate
the safety and tolerability of itruvone in healthy adult subjects.
The study is intended to confirm the favorable safety profile of
itruvone established in three previous clinical studies conducted
in Mexico, including a published Phase 2A study of itruvone as a
stand-alone treatment of MDD, as well as facilitate Phase 2B
development of itruvone as a stand-alone treatment for MDD.
Vistagen anticipates top line results in Q2 2023.
“With the treatment protocol for our final enrolled participant
complete, we look forward to reviewing the data and advancing Phase
2B development plans for itruvone as an innovative treatment for
major depressive disorder,” said Shawn Singh, Chief Executive
Officer of Vistagen. “Major depressive disorder continues to
disrupt the lives of millions of individuals and there is clear
need for safer, more effective treatments, especially treatments
with potential for rapid-onset and sustained benefits without
causing sexual side effects or weight gain. We anticipate this U.S.
Phase 1 trial will build on itruvone’s exceptional safety and
tolerability profile as demonstrated in all prior clinical studies
to date.”
About Itruvone (PH10)
Itruvone (PH10) is an investigational pherine nasal spray
designed with a potential rapid-onset mechanism of action (MOA)
that is fundamentally differentiated from the MOA of all currently
approved treatments for depression disorders. Itruvone, which is
administered at microgram-level doses, is designed to engage and
activate chemosensory neurons in the nasal passages connected to
neural circuits in the brain that produce antidepressant effects.
Specifically, itruvone’s proposed MOA involves binding to receptors
of chemosensory neurons in the nasal passages that regulate the
olfactory-amygdala neural circuits believed to increase the
activity of the limbic-hypothalamic sympathetic nervous system and
increase the release of catecholamines. Importantly, unlike all
currently approved oral antidepressants and rapid-onset
ketamine-based therapy (KBT), including both intravenous ketamine
and intranasal ketamine, we believe itruvone does not require
systemic uptake or brain penetration to produce rapid-onset of
antidepressant effects, avoiding side effects and safety concerns
potentially associated with rapid-onset KBT and longer acting oral
antidepressants.
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 for
treatment of anxiety and depression disorders. Several of
Vistagen’s product candidates belong to a new class of drugs known
as pherines, which are designed with a novel rapid-onset mechanism
of action that activates chemosensory neurons in the nasal passages
and can impact key 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 Vistagen’s drug candidates, including
itruvone (PH10), will successfully complete ongoing or future
clinical trials, receive regulatory approval or be commercially
successful. Other factors that may cause such a difference include,
without limitation, risks and uncertainties relating to the
Company’s ongoing clinical studies of fasedienol (PH94B), itruvone
and AV-101; delays in launching, conducting and/or completing
ongoing and/or planned clinical trials; fluctuating costs of
materials and other resources required to conduct the Company’s
ongoing and/or planned clinical and non-clinical trials; the scope
of protection provided by the U.S. patents issued for any of the
Company’s drug candidates will be sufficient to deter competition;
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. Certain of these risks and others 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 December 31, 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/20230308005334/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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