Vistagen Announces Positive Results from Exploratory Phase 2A Study of PH80 in Women Diagnosed with Menopausal Hot Flashes - Seite 2

“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.