PH80 nasal spray demonstrates statistically
significant efficacy versus placebo in exploratory double-blind,
placebo-controlled Phase 2A study (n=36) in women diagnosed with
menopausal hot flashes
PH80 was safe and well-tolerated with an
adverse event profile similar to placebo
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 PH80, one of the Company’s
five investigational neuroactive nasal sprays, demonstrated
statistically significant efficacy versus placebo in an exploratory
Phase 2A study for the acute treatment of hot flashes (vasomotor
symptoms) in women diagnosed with menopausal hot flashes.
The randomized, double-blind, placebo-controlled exploratory
Phase 2A clinical study of PH80 was designed to explore the
efficacy, safety, and tolerability of intranasal administration of
PH80 for the acute management of menopausal hot flashes in women.
In the study, PH80 nasal spray containing epoxyestrenolone 0.8
micrograms/50 microliters (0.8 µg/50 µL) was self-administered by
subjects intranasally, two sprays in each nostril (total dose =
3.2µg) up to four times daily, as-needed for four consecutive
weeks. One additional dose was allowed at night if subjects were
awakened by hot flashes. Through the course of the study, subjects
recorded the number, severity, disruption in function, and sweating
related to hot flashes. PH80 was well-tolerated with no serious
adverse events, and the adverse event profiles were comparable
between PH80 and placebo. All 36 subjects completed four weeks of
treatment and no subject discontinued participation in the study as
a result of adverse events.
PH80 induced significant reduction in the daily number of hot
flashes compared to placebo at the end of the first week of
treatment, and the improvement was maintained through each
treatment week until the end of the treatment period. At baseline,
subjects reported a mean daily number of hot flashes of 7.7 (PH80,
n=18) and 8.0 (placebo, n=18). After one week of treatment, the
number of hot flashes dropped to 2.8 (PH80) and 6.4 (placebo)
(p<.001) and after four weeks of treatment the number of hot
flashes dropped to 1.5 (PH80) and 5.1 (placebo) (p<.001). PH80
treatment also significantly reduced the severity, disruption in
function, and sweating related to hot flashes during the treatment
period as compared with placebo.
“The previously unreported results of this exploratory Phase 2A
clinical study of PH80 for treatment of menopausal hot flashes are
yet another part of the promising larger body of evidence regarding
the potential of our innovative pherine nasal spray pipeline,” said
Shawn Singh, Chief Executive Officer of Vistagen. “There is clearly
a need for an alternative treatment option for menopausal hot
flashes that provides rapid relief without the safety, side
effects, and treatment burden of the currently available options.
We are encouraged by the potential that PH80 holds to improve the
treatment paradigm for hot flashes and reduce the serious physical
burden on the quality of life experienced by millions of women
worldwide.”
This exploratory Phase 2A study of PH80 was conducted in a
real-world setting in Mexico and was sponsored by Pherin
Pharmaceuticals (Pherin), now a wholly owned subsidiary of
Vistagen, prior to Vistagen’s acquisition of Pherin in February
2023. Ellen Freeman, Ph.D. of the University of Pennsylvania served
as the Principal Investigator of the study. Vistagen’s pipeline now
includes six clinical-stage drug candidates, including its most
advanced pherine nasal spray, fasedienol (PH94B), which is in Phase
3 development for treatment of social anxiety disorder.
About PH80
PH80 is a first-in-class, rapid-onset product candidate,
designed to be used in a manner analogous to a rescue inhaler for
asthma, with user-friendly, patient-tailored intranasal
administration as-needed up to multiple times daily. The proposed
mechanism of action of PH80 nasal spray does not require systemic
uptake or direct action on CNS neurons and has demonstrated an
excellent safety profile in all clinical trials to date. Vistagen
is developing PH80 as a potential new treatment for the acute
management of menopausal hot flashes and, potentially, acute
treatment of migraine. Designed for intranasal administration in
low microgram doses, the proposed novel MOA of PH80 is
fundamentally differentiated from all currently approved treatment
options and has potential to be a rapid-onset intervention that is
safe to use for patients who choose not to be treated with
presently available therapies, including hormone replacement
therapy, certain antidepressants, and a neurokinin 3 (NK3) receptor
antagonist.
About Hot Flashes
Hot flashes are vasomotor symptoms commonly experienced by women
in menopause and are accompanied by hallmark symptoms such as
sudden feelings of warmth, night sweats, and flushed skin.
Presentation of hot flashes is directly linked to changes in
hormone levels due to menopause, or menopause induced by other
medical treatments or co-existing conditions, and the causal
mechanism is unclear. Hot flashes are the most common symptom of
the menopausal transition, affecting about 75% of menopausal women
and about 40% of women in perimenopause. Prevalence of hot flashes
is estimated to be about 20 million women in the U.S. with 9
million women estimated to be suffering from severe hot flashes.
Current pharmacotherapies to treat hot flashes include hormonal
therapy (estrogen with or without progesterone, or a synthetic
progestin), gabapentins, certain antidepressants, clonidine, and
fezolinetant, a neurokinin 3 (NK3) receptor antagonist, all of
which are associated with certain side effects and safety
concerns.
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, in addition to AV-101, an oral 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 can selectively and
beneficially impact key neural circuits in the brain without
requiring systemic uptake or direct activity on CNS neurons.
Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR
but does not block it. 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 development
may differ materially from those projected or implied in these
forward-looking statements. Among other things, there can be no
guarantee that any of the Company’s drug candidates will
successfully complete ongoing or 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 PH80. 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 the
Company’s product candidates; other risks and uncertainties related
to delays in launching, conducting and/or completing ongoing and
planned clinical trials; the scope and enforceability of the
Company’s patents, including patents related to the Company’s
pherine drug candidates; fluctuating costs of materials and other
resources and services 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 drug candidates. 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 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. Additionally,
you should not place undue reliance on these forward-looking
statements in the future, because they 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230607005382/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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