Vistagen Reports New Preclinical Data Supporting Itruvone (PH10) Nasal Spray’s Potential Antidepressant Activity via Peripheral Nasal Neurons without Entry into the Brain
17 Julho 2023 - 9:00AM
Business Wire
Preclinical study of radiolabeled intranasal
itruvone in laboratory rats further validates itruvone’s potential
to treat major depressive disorder (MDD) without systemic
absorption
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 new mechanism of action data from
a preclinical tissue distribution study in laboratory rats. The
study demonstrated that a single intranasal administration of
radiolabeled itruvone ([14C]PH10) was essentially undetectable in
the brain and most other tissues, including blood and plasma.
These new data further support the proposed mechanism of action
of itruvone nasal spray as involving binding to receptors of
peripheral chemosensory neurons in the nasal cavity, but not to
neuronal receptors in the CNS, and thereby limiting transport of
molecules to the circulatory system and minimizing potential
systemic exposure.
“Itruvone’s unique mechanism of action is further demonstrated
in this new carbon-labeled study,” said Shawn Singh, Chief
Executive Officer of Vistagen. “These new data and previously
announced preclinical electrophysiology data demonstrating that
itruvone’s mechanism of action does not involve direct activation
of GABA-A receptors in the brain, as well as other completed Phase
1 and Phase 2A clinical studies, provide a substantial body of
evidence supporting itruvone’s exceptionally favorable safety
profile. Currently approved medications to treat depression require
systemic absorption. This can lead to unwanted side effects and
create potential drug-drug interaction concerns for some
individuals who require additional medications for other medical
conditions. As a potential non-systemic treatment option, we
believe itruvone has a vital opportunity to change the treatment
paradigm for the growing numbers of individuals suffering from
depression disorders across the globe.”
Vistagen recently reported that itruvone is now staged for
potential Phase 2B clinical development in the U.S. as a
stand-alone treatment for MDD, building on previously published
results from a randomized, double-blind, placebo-controlled Phase
2A study of itruvone in MDD. In that study, itruvone was
administered intranasally at a daily dose of 3.2 μg and 6.4 μg for
8 weeks. After one week of treatment, the mean reduction on the
17-item Hamilton Depression Scale (HAM-D-17) scores for the
itruvone 6.4 μg group was 10.1 points, which was statistically
greater (p = 0.03) than the mean reduction in the placebo group of
4.2 points from baseline. Also, at the end of the last week of
treatment (Week 8) in that study, the itruvone 6.4 μg group showed
a mean HAM-D-17 score reduction of 17.8, which was statistically
greater than the mean reduction in the placebo group of 10.9 points
from baseline (p = 0.02). Thus, in the itruvone 6.4 μg treatment
group, the HAM-D-17 score improved significantly from the baseline
within one week and this effect was sustained until the Week 8
study endpoint. Notably, both the itruvone 3.2 μg and 6.4 μg
treatment groups showed strong effect sizes after one week of
treatment (0.72 for the 3.2 μg dose and 1.01 for the 6.4 μg dose)
and at the Week 8 study endpoint (0.74 for the 3.2 μg dose and 0.95
for the 6.4 μg dose). There were no reports of SAEs. Itruvone was
well-tolerated and did not cause psychological side effects (such
as dissociation or hallucinations) or other safety concerns that
may be associated with other approved pharmacological therapies for
MDD.
About Itruvone (PH10)
Itruvone (PH10) is an investigational pherine nasal spray
designed with a potential mechanism of action (MOA) that is
fundamentally differentiated from the MOA of all currently approved
treatments for depression disorders. Itruvone is administered at
microgram-level doses and is designed to engage and activate
chemosensory neurons in the nasal cavity 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 cavity 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 ketamine-based therapy
(KBT), including both intravenous ketamine and intranasal ketamine,
we believe itruvone does not require systemic absorption or brain
penetration to produce antidepressant effects, while avoiding side
effects and safety concerns potentially associated with KBT and
longer acting oral antidepressants. The FDA has granted Fast Track
designation for the development of itruvone as a potential
treatment for major depressive disorder.
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. Vistagen is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those currently available for the treatment
of anxiety, depression and multiple CNS disorders. Vistagen’s
pipeline includes six clinical-stage product candidates, including
fasedienol (PH94B), itruvone (PH10), PH15, PH80, and PH284, each an
investigational agent belonging to a new class of drugs known as
pherines, as well as AV-101, which is an oral prodrug antagonist of
the N-methyl-D-aspartate receptor (NMDAR). Pherines are
administered as low microgram dose level nasal sprays and are
designed with a novel mechanism of action that activates
chemosensory neurons in the nasal cavity and can beneficially
impact key neural circuits in the brain 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, depression and several other
CNS disorders. 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, will successfully complete future clinical trials,
receive regulatory approval or be commercially successful or that
future studies will replicate results from prior non-clinical
and/or clinical studies for any of Vistagen’s drug candidates.
Other factors that may cause such a difference include, without
limitation, risks and uncertainties relating to securing sufficient
financing or third-party collaborative support to launch, conduct
and complete clinical development and commercialization of itruvone
or any of the Company's other product candidates; delays in
launching, conducting and/or completing ongoing and/or planned
clinical trials of itruvone or any of the Company’s other product
candidates; 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, 2023, 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/20230716914719/en/
Investors Mark McPartland Senior Vice President, Investor
Relations (650) 577-3606 markmcp@vistagen.com
Media Nate Hitchings SKDK nhitchings@skdknick.com
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