PH15 nasal spray demonstrates statistically
significant efficacy versus placebo and caffeine in a
placebo-controlled Phase 2A pilot study in sleep-deprived
participants
PH15 was safe and well-tolerated with an
adverse event profile similar to placebo
Vistagen (Nasdaq: VTGN), a biopharmaceutical company pioneering
neuroscience to deliver groundbreaking therapies for individuals
affected by psychiatric and neurological disorders, today announced
positive results from a Phase 2A pilot study of PH15, an
investigational pherine nasal spray, for improvement of psychomotor
impairment caused by mental fatigue. PH15 demonstrated a
statistically significant improvement in reaction time compared to
placebo and caffeine in sleep-deprived study participants.
The previously unreported randomized, double-blind,
placebo-controlled, crossover Phase 2A pilot study of PH15 was
designed to explore the efficacy, safety, and tolerability of
intranasal administration of PH15 on psychomotor performance as
measured by reaction time in sleep-deprived participants. Ten
participants were randomly administered PH15 (multiple 1.6 µg
doses, total dose of 9.6 µg), placebo (nasal spray and oral), or
caffeine (single 400 mg oral dose administered 1 hour before the
session) in sequential sleep deprivation study sessions spaced one
week apart. During each sleep deprivation session, participants
received blinded treatments before the start of each of four
testing periods, at 6:00 p.m., 9:00 p.m., midnight, and 3:00 a.m.
The participants’ reaction times to both isochronous (regular
interval) and stochastic (random interval) “flash” light stimuli
were computer-measured during each testing period as participants
responded to the luminous stimuli.
Statistically Significant Efficacy
During both isochronous and stochastic reaction time tests,
administration of 1.6 µg PH15 nasal spray induced a significantly
faster mean reaction time compared to placebo nasal spray across
all time points (p<0.001). PH15 also demonstrated a
statistically significant improvement in reaction time compared to
oral caffeine (p<0.001) for both reaction time tests during the
testing periods at midnight and 3:00 a.m. when subjects were most
fatigued.
Well-tolerated Therapy
PH15 was well-tolerated with no serious adverse events reported.
The adverse event profiles of PH15 and placebo were comparable,
with brief nasal itching in one PH15-dosed participant and three
placebo-dosed subjects. Participants on oral caffeine, however,
experienced palpitations, euphoria, dry mouth, stomachache, and
polyuria.
“In this Phase 2A pilot study, PH15 nasal spray demonstrated
significant improvement in reaction time when compared to both oral
caffeine and placebo in sleep-deprived participants. These pilot
findings contribute to our confidence in PH15’s potential as an
innovative treatment for enhancing psychomotor performance and
potentially cognitive impairment, particularly in addressing the
challenges of mental fatigue,” said Shawn Singh, Chief Executive
Officer of Vistagen. “Numerous disorders, such as shift work
disorder, sleep apnea, and narcolepsy, can lead to debilitating
sleep deprivation and mental fatigue. Individuals affected by these
disorders require improved treatment options with a differentiated
safety profile, one without the potential for abuse liability or
negative and treatment-limiting side effects and safety concerns.
We anticipate exploring PH15’s potential to emerge as a new and
transformative solution for these underserved individuals.”
This previously unreported Phase 2A pilot study of PH15 was
sponsored by Pherin Pharmaceuticals (Pherin), now a wholly owned
subsidiary of Vistagen, and conducted at the National Institute of
Psychiatry, Sleep Disorders Clinic in Mexico City, Mexico in 2011.
Vistagen gained access to the results of this study in connection
with its acquisition of Pherin in February 2023. The late Jose
Maria Calvo, MD, formerly Associate Professor, National Institute
of Psychiatry in Mexico City, served as the Principal Investigator
of the study.
About Pherines
Pherines are novel neurocircuitry-focused drug candidates
delivered intranasally for treatment of psychiatric and
neurological disorders. The proposed mechanisms of action (MOAs) of
pherines are fundamentally differentiated from the MOAs of all
approved drugs, offering a new standard of care for multiple
central nervous system (CNS) disorders. Their effect on the CNS is
through the activation of nasal chemosensory receptors, which send
signals through neural circuitry to specific brain regions. The
novel nose-to-brain MOAs of pherines offer the potential to deliver
meaningful, rapid-onset efficacy and a differentiated safety
profile, without systemic absorption or CNS uptake. All of the five
pherines in Vistagen’s clinical-stage neuroscience pipeline have
demonstrated a favorable safety profile in clinical trials
completed to date.
About PH15
PH15 is an odorless, tasteless synthetic investigational pherine
with a novel, rapid-onset proposed mechanism of action (MOA) that
is fundamentally differentiated from the MOA of all currently
approved treatments to improve psychomotor or cognitive impairment
caused by mental fatigue. PH15’s proposed MOA targets nasal
receptors that activate olfactory-amygdala and olfactory
hippocampus neural circuits in the limbic system that are known to
be associated with psychomotor activity and cognition, without
requiring systemic absorption or direct action on neurons in the
brain. PH15 has demonstrated an excellent safety profile in all
clinical trials completed to date. Vistagen is currently evaluating
the potential Phase 2 development path forward for PH15 and a
nonclinical program required to support a U.S. Investigational New
Drug application to facilitate further Phase 2 development of PH15
in the U.S.
About Vistagen
Vistagen (Nasdaq: VTGN) is a biopharmaceutical company
pioneering neuroscience to deliver groundbreaking therapies for
individuals affected by psychiatric and neurological disorders.
Five of Vistagen’s clinical-stage neuroscience pipeline candidates
belong to a new class of drugs known as pherines, which are
investigational neuroactive nasal sprays with innovative proposed
mechanisms of action that activate chemosensory neurons in the
nasal passages to impact fundamental neural circuitry in the brain
without the need for systemic absorption or binding to receptors in
the brain. Vistagen’s sixth investigational candidate is an oral
prodrug with potential to modulate NMDA receptor activity. At
Vistagen, we are passionate about delivering differentiated
treatments that set new standards of care for people living with
anxiety, depression, and other neurological 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 any of its product candidates, including PH15. Other
factors that may cause such a difference include, without
limitation, risks and uncertainties related to delays in launching,
conducting and/or completing nonclinical programs for any of the
Company’s drug candidates, including PH15; launching, conducting
and/or completing ongoing and future clinical trials for any of the
Company’s drug candidates; the scope and enforceability of the
Company’s patents; the Company’s ability to secure adequate
financing for clinical development of certain of its drug
candidates; fluctuating costs of materials and other resources and
services required to conduct the Company’s ongoing and/or future
clinical and nonclinical 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 December 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. 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/20240425871950/en/
Investors: Mark McPartland (650) 577-3606 markmcp@vistagen.com
Media: Caren Scannell (650) 577-3601 cscannell@vistagen.com
VistaGen Therapeutics (NASDAQ:VTGN)
過去 株価チャート
から 4 2024 まで 5 2024
VistaGen Therapeutics (NASDAQ:VTGN)
過去 株価チャート
から 5 2023 まで 5 2024
