SOUTH SAN FRANCISCO - Vistagen Therapeutics, a biopharmaceutical company focusing on treatments for psychiatric and neurological disorders, has reported positive results from a Phase 2A pilot study of its investigational nasal spray, PH15. The study found that PH15 significantly improved reaction times in sleep-deprived individuals compared to placebo and caffeine.
The double-blind, placebo-controlled, crossover study was designed to evaluate the efficacy, safety, and tolerability of PH15 on psychomotor performance in sleep-deprived participants. The trial involved ten participants who were administered multiple doses of PH15, a placebo, or a single oral dose of caffeine in sessions spaced a week apart. Reaction times were measured in response to visual stimuli at various points during the night.
Results indicated that PH15 administration led to a notably faster mean reaction time compared to the placebo across all time points, with statistical significance (p<0.001). Additionally, PH15 outperformed oral caffeine during periods of peak fatigue at midnight and 3:00 a.m. (p<0.001).
In terms of safety, PH15 was well-received with no serious adverse events reported. The adverse event profile was similar to that of the placebo, with the exception of brief nasal itching in one participant who received PH15. Those who took caffeine experienced side effects such as palpitations and dry mouth.
Shawn Singh, CEO of Vistagen, expressed optimism about PH15's potential as a treatment for psychomotor performance and cognitive impairment due to mental fatigue. He highlighted the need for better treatment options for conditions like shift work disorder and narcolepsy that lead to sleep deprivation and mental fatigue.
The study was originally conducted by Pherin Pharmaceuticals, now a subsidiary of Vistagen, at the National Institute of Psychiatry, Sleep Disorders Clinic in Mexico City in 2011. Vistagen acquired the study results following its acquisition of Pherin in February 2023.
Pherines, the class of drugs to which PH15 belongs, are novel neuroactive nasal sprays with a unique mechanism of action. They are designed to activate chemosensory receptors in the nasal passages, impacting neural circuitry in the brain without systemic absorption or direct brain receptor binding.
Vistagen is currently evaluating the next steps for PH15's clinical development, including a nonclinical program to support an Investigational New Drug application for further Phase 2 trials in the U.S.
This article is based on a press release statement from Vistagen.
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