VistaGen Therapeutics Acquires Worldwide Rights to Develop and Commercialize PH10

VistaGen Therapeutics (NASDAQ:VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system diseases and disorders with high unmet need, today announced that the Company has exercised its option to acquire from Pherin Pharmaceuticals the exclusive license for worldwide rights to develop and commercialize PH10, a first-in-class, intranasally administered neuroactive steroid, with rapid-onset antidepressant effects for treatment of major depressive disorder demonstrated in a phase 2a study.

As quoted in the press release:

The Company secured the option for PH10 concurrently with its previously announced license agreement with Pherin for worldwide rights to develop and commercialize PH94B, also a first-in-class neuroactive pherine, which VistaGen is preparing for pivotal Phase 3 development as a nasal spray for acute on-demand treatment of social anxiety disorder (SAD).

PH10 activates nasal chemosensory receptors that in turn engage GABA (gamma-aminobutyric acid) and CRH (corticotropin-releasing hormone) neurons in the limbic amygdala system. The activation of these neural circuits is believed to have the potential to lead to a rapid antidepressant effect.

Michael Liebowitz, M.D., a member of VistaGen’s CNS Clinical and Regulatory Advisory Board, has acted as an advisor to Pherin in connection with its clinical trials of PH10 and PH94B and previously presented results for PH10’s eight-week, double-blind, single-center, 30-patient, Phase 2a study for MDD. Results in the Phase 2a study demonstrated that self-administered doses of PH10 as a nasal spray resulted in significant decreases in depression as measured by the Hamilton Rating Scale for Depression, a widely used clinician-administered depression assessment scale. In this study, PH10 was very well tolerated with minimal side effects.

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