The U.S. Phase 1 data build on successful Phase
1 and Phase 2A clinical studies of itruvone previously conducted
outside the U.S.
Itruvone was well-tolerated and demonstrated a
favorable safety and tolerability profile across single and
multiple dose intranasal administrations
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 favorable safety and tolerability
data from its U.S. Phase 1 clinical trial of itruvone (PH10), the
Company’s investigational rapid-onset pherine nasal spray for the
treatment of major depressive disorder (MDD). Results from the U.S.
Phase 1 study build on successful Phase 1 studies and a positive
randomized, double-blind, placebo-controlled Phase 2A study of
itruvone nasal spray in MDD previously conducted in Mexico and
enable Phase 2B development of itruvone in the U.S. as an
innovative stand-alone rapid-onset product candidate for treatment
of MDD.
The U.S. Phase 1 study was a randomized, double-blind,
placebo-controlled clinical study investigating the safety and
tolerability of a single dose and of multiple doses of itruvone
nasal spray in healthy adult subjects. There were no reported
serious adverse events (SAEs) or discontinuations due to adverse
events (AEs) in the study. Two AEs were reported during the
treatment period, fatigue and headache, which occurred in the same
subject. Both AEs were mild in severity and resolved without
sequelae. Overall, itruvone nasal spray was well-tolerated and
demonstrated a favorable safety profile, consistent with the three
prior clinical studies of itruvone, including a positive
randomized, double-blind, placebo-controlled Phase 2A study in
MDD.
“According to a recent Gallup survey, more than a quarter of
American adults have been diagnosed with depression at some point
in their lifetime. The need for faster-acting, safer and more
effective medications is unrelenting, especially in an environment
where the gap between innovative treatment options and the
prevalence of depressive disorders is increasing,” stated Shawn
Singh, Chief Executive Officer of Vistagen. “With a successful
Phase 1 study in the U.S. and a positive Phase 2A study conducted
outside the U.S. in hand, we look forward to advancing itruvone
into Phase 2B development in the U.S., on our own or with a
partner.”
Itruvone Published Phase 2A Results in Major Depressive
Disorder
The confirmation of itruvone’s safety profile demonstrated in
the U.S. Phase 1 study, along with the results of Vistagen’s
nonclinical studies and three prior clinical studies, inform Phase
2B development of itruvone as a potential rapid-onset stand-alone
treatment of MDD with a favorable safety profile. In the published
randomized, double-blind, placebo-controlled parallel design Phase
2A study of itruvone in MDD, itruvone was administered intranasally
at a daily dose of 3.2μg and 6.4μg 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 6.4μg
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),
the itruvone 6.4μg 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 6.4μg 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 3.2μg and 6.4μg treatment groups showed strong effect
sizes after one week of treatment (0.72 for the 3.2μg dose and 1.01
for the 6.4μg dose) and at the Week 8 study endpoint (0.74 for the
3.2μg dose and 0.95 for the 6.4μg 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.
More information about the itruvone Phase 2A study in MDD can be
found in the peer-reviewed article, “A Placebo Controlled Trial of
PH10: Test of a New Rapidly Acting Intranasally Administered
Antidepressant,” published in the November-December 2019 edition of
the British Journal of Pharmaceutical and Medical Research.
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 nasal spray,
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, our
data show itruvone does not require systemic uptake or brain
penetration to produce rapid-onset of antidepressant effects,
potentially avoiding side effects and safety concerns associated
with KBT and longer acting oral antidepressants.
The FDA has granted Fast Track designation for 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 that are currently available for
treatment of anxiety, depression and multiple CNS disorders.
Vistagen’s pipeline includes six clinical-stage product candidates,
including five investigational agents belonging to a new class of
drugs known as pherines and an oral prodrug of 7-Cl-CYNA, which is
a full antagonist of the glycine site of the N-methyl-D-aspartate
receptor (NMDAR). Pherines, which are administered as nasal sprays,
are designed with an innovative rapid-onset mechanism of action
that activates chemosensory neurons in the nasal passages and
selectively impact key neural circuits in the brain without
requiring systemic uptake or direct activity on CNS neurons.
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 will
successfully complete future clinical trials, receive regulatory
approval or be commercially successful, or that the Company will be
able to successfully replicate the result of past studies of its
product candidates, including itruvone. Other factors that may
cause such a difference include, without limitation, risks and
uncertainties relating to the Company’s ability to secure adequate
financing for its operations, including financing or collaborative
support for continued clinical development of itruvone and/ or the
Company’s other product candidates; other risks and uncertainties
related to delays in launching, conducting and/or completing
ongoing and 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; that the scope and
enforceability of protection provided by 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 any of the
Company’s product 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/20230621794406/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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