Vistagen Announces Positive Results from Phase 2A Pilot Study of PH15 for Improvement of Psychomotor Impairment Caused by Mental Fatigue
- PH15 nasal spray showed statistically significant improvement in reaction time compared to placebo and caffeine in sleep-deprived participants.
- PH15 demonstrated faster mean reaction time compared to placebo and oral caffeine during specific testing periods, notably at midnight and 3:00 a.m.
- The adverse event profile of PH15 was comparable to placebo, with no serious adverse events reported.
- The study highlights the potential of PH15 as a treatment option for mental fatigue and related disorders, offering a differentiated safety profile.
- The Phase 2A pilot study was conducted in 2011 and sponsored by Pherin Pharmaceuticals, now a wholly owned subsidiary of Vistagen.
- Results of the study were obtained following Vistagen's acquisition of Pherin in February 2023.
- None.
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
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
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
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
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Investors:
Mark McPartland
(650) 577-3606
markmcp@vistagen.com
Media:
Caren Scannell
(650) 577-3601
cscannell@vistagen.com
Source: Vistagen
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