PH80 nasal spray demonstrated statistically and
clinically significant improvement versus placebo in an exploratory
double-blind, placebo-controlled Phase 2A study (n=52) in subjects
with a history of premenstrual dysphoric disorder (PMDD)
PH80 was well-tolerated with an adverse event
profile similar to placebo
Data builds on the previously reported
vasomotor symptoms (hot flashes) due to menopause study,
reinforcing the potential of PH80 to treat multiple aspects of
women’s health
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 improvement versus placebo in an
exploratory Phase 2A study for acute management of the symptoms of
premenstrual dysphoric disorder (PMDD), including negative mood and
physical and behavioral symptoms.
The previously unreported randomized, double-blind,
placebo-controlled 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 PMDD in subjects
with a regular menstrual cycle and at least a one-year history of
PMDD. The initial study visit occurred after the onset of symptoms.
All subjects were administered placebo nasal spray and those who
showed no symptom improvement were eligible to return for the
second visit, which occurred after the onset of symptoms during the
next menstrual cycle. At the second study visit, subjects were
randomized to receive a single dose of 0.9 µg PH80 nasal spray or
placebo in the clinic. Subsequent doses of PH80 or placebo were
then self-administered at home as-needed, up to four times per day
for six consecutive days prior to the estimated day of menses
onset.
PH80 demonstrated statistically and clinically significant
improvement versus placebo in symptoms of PMDD using the
subject-rated Penn Daily Symptom Report (DSR) as early as Day 4 and
continuing to Day 6. At Day 6, change from baseline was -12.1 for
PH80 (n=29) versus -7.6 for placebo (n=23) (p=0.008), showing
significant and clinically meaningful improvement. PH80 also
demonstrated statistically and clinically significant improvement
versus placebo at Day 6 on the clinician-rated Premenstrual Tension
Scale (PMTS) total score where the PH80 change from baseline was
-12.0 versus -7.7 for placebo (p=0.006). PH80 was well-tolerated
with no serious adverse events (AEs). The most common AE was
headache, reported by 17% in the placebo group and 7% in the PH80
group. No other treatment-emergent AE occurred more than once per
subject.
Analysis of the data revealed that mood symptoms seemed to be
the most sensitive to PH80:
- Depression/feeling sad or blue was reported by 0% of PH80 and
68% of placebo-treated subjects;
- Irritability/persistent anger was reported by <3% of PH80
and 43% of placebo-treated subjects;
- Anxiety/tension/on edge was reported by 0% of PH80 and 35% of
placebo-treated subjects; and
- Difficulty concentrating was reported by 0% of PH80 and 18% of
placebo-treated subjects.
“Symptoms of PMDD affect 5% to 8% of menarcheal individuals and
there are limited effective treatment options that help with both
physical and mood symptoms. The previously unreported results of
this exploratory Phase 2A clinical study of PH80 signal a potential
revolutionary method for treating premenstrual mood symptoms,” said
Shawn Singh, Chief Executive Officer of Vistagen. “PMDD symptoms
can be extremely limiting to daily functioning and PH80
demonstrated the potential to alleviate these symptoms.
Interestingly, improvements in the mood items of depression and
dysphoria were observed both by subject- and clinician-rated
scales. Along with the previously reported efficacy of PH80 for the
treatment of hot flashes due to menopause, PH80 efficacy in PMDD
further supports its potential as a valuable and differentiated
treatment option for multiple indications in women’s
healthcare."
This previously unreported exploratory Phase 2A study of PH80
was sponsored by Pherin Pharmaceuticals (Pherin), now a wholly
owned subsidiary of Vistagen, and conducted in a real-world setting
in Mexico in 2005 and 2006. Vistagen gained access to the results
of the study in connection with its acquisition of Pherin in
February 2023. Ellen Freeman, Ph.D., formerly of the University of
Pennsylvania, served as the Principal Investigator of the study.
Vistagen recently entered into an exclusive negotiation agreement
with Fuji Pharma Co., Ltd. regarding a potential license to develop
and commercialize PH80 in Japan, including for the acute treatment
of moderate to severe hot flashes due to menopause and potentially
other indications.
Vistagen’s pipeline includes six clinical-stage drug candidates,
including its most advanced neuroactive pherine nasal spray,
fasedienol (PH94B), for which Vistagen recently reported positive
top-line results from its PALISADE-2 Phase 3 trial in social
anxiety disorder.
About PH80
PH80 is a first-in-class, neuroactive pherine nasal spray. The
proposed mechanism of action of PH80 nasal spray does not require
systemic absorption or direct activity on neurons in the brain 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 vasomotor symptoms (hot flashes) due to
menopause, PMDD, and potentially other disorders. Designed for
intranasal administration in low microgram doses, the proposed
novel mechanism of action of PH80 is fundamentally differentiated
from all currently approved treatment options in women’s
healthcare.
About Premenstrual Dysphoric Disorder
According to the National Institutes of Health (NIH), 5% to 8%
of menarcheal individuals have moderate-to-severe symptoms that can
cause significant distress and functional impairment, suggestive of
premenstrual dysphoric disorder (PMDD). PMDD is a severe, sometimes
disabling extension of premenstrual syndrome (PMS). PMDD symptoms
usually begin in the luteal phase (approximately seven to 10 days
before a person’s period starts) and continue for the first few
days of the period. Like PMS, PMDD can cause bloating, breast
tenderness, fatigue, and changes in sleep and eating habits, but
distinctively, it can also cause extreme mood shifts that can
disrupt daily life and damage relationships. The cause of PMDD is
not clearly understood, but it is thought that neurotransmitter
systems may trigger PMDD. Brain areas that regulate emotion and
behavior are studded with receptors for estrogen, progesterone, and
other sex hormones. These hormones affect the functioning of
neurotransmitter systems that influence mood and thinking, possibly
triggering PMDD. Treatment of PMDD is aimed at preventing or
minimizing symptomology.
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), PH80, PH15, 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 of an
antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines
are neuroactive nasal sprays designed with an innovative proposed
mechanism of action that activates chemosensory neurons in the
nasal cavity and can beneficially impact key neural circuits in the
brain without systemic absorption or direct activity on 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 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, 2023, and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended June 30, 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230912021668/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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