SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced that the Company has taken important strategic steps to secure additional patent protection for its lead product candidate, PH94B, through the recent filing of national applications at the U.S. Patent and Trademark Office (USPTO) and counterpart patent authorities in major pharmaceutical markets outside the U.S. for the treatment of adjustment disorder (AjD).
These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).
Vistagen recently announced its pending acquisition of Pherin Pharmaceuticals, Inc. Upon closing of the acquisition, which is subject to certain customary closing conditions, Vistagen will acquire Pherin’s entire pherine pipeline, resulting in Vistagen gaining full ownership of intellectual property rights to PH94B, which is currently in Phase 3 development for SAD and Phase 2 development for AjD with anxiety (AjDA), and PH10, which is in clinical development for MDD. Vistagen will also gain full ownership of three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH284 for appetite-related disorders and PH80 for migraine and hot flashes. When the acquisition is completed, Vistagen's global patent portfolio for novel pherine class compounds will further expand to include U.S. and foreign counterpart patent applications related to the use of PH80 for the treatment of migraine and for the treatment of hot flashes.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The Company is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available. Vistagen’s clinical-stage candidates are targeting multiple types of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are odorless and tasteless investigational neuroactive steroids designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression. Connect at www.Vistagen.com.
About Adjustment Disorder
Adjustment disorder (AjD) refers to a maladaptive emotional or behavioral response to an identifiable stressor. AjD occurs within three months of exposure to the stressor as evidenced by marked distress that is out of proportion to the socially or culturally expected reactions to the stressor, or that represents significant impairment in social, occupational or other important areas of daily functioning. Current pharmacological treatments for AjD vary widely and include antidepressants, benzodiazepines, buspirone and natural products such as cannabidiol. Vistagen’s ongoing exploratory Phase 2A clinical program for PH94B in AjD is focused on adults experiencing AjD with anxiety (AjDA). The randomized, double-blind, placebo-controlled study in AjDA in adults involves daily use of PH94B administered four times per day in a real-world outpatient setting for 28 days. Vistagen expects top line results from the study in Q1 2023.
