VistaGen Therapeutics (NASDAQ: VTGN) today announced that the Japan Patent Office (JPO) has issued a patent related to methods of treating depression with AV-101, VistaGen’s oral NMDA receptor glycine site antagonist in Phase 2 development for treatment of major depressive disorder (JP 6436913B). This patent also relates to methods of treating hyperalgesia, which is extreme sensitivity to pain. The new AV-101 Japanese patent will not expire until at least 2034.
“Development and commercialization of our CNS pipeline in Japan, together with the U.S., China and the European Union, is among our top corporate priorities, stated Shawn Singh, Chief Executive Officer. “Together with our previously obtained Japanese patent for the synthesis of AV-101, this key patent now expands commercial protection of AV-101 in Japan, one of the world’s largest pharmaceutical markets, a market with a strong long-term track record of innovative and successful neuropsychiatry products.”
About AV-101 VistaGen’s AV-101 (4-Cl-KYN) is an investigational, oral NMDA receptor glycine site antagonist with potential to be a treatment for multiple CNS indications with high unmet need. AV-101 is currently in Phase 2 clinical development in the U.S. for major depressive disorder (MDD) and in a first-step target engagement study in healthy volunteer U.S. military Veterans for suicidal ideation. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment of MDD and as a non-opioid treatment for neuropathic pain.
About Major Depressive Disorder (MDD)MDD affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide. Individuals with depression, including MDD, experience continuous suffering from a serious, biologically based disease which has a significant negative impact on all aspects of life, including quality of life. While current antidepressants are widely used for treatment, large-scale studies have suggested that the drug-treated MDD market is substantially underserved by current medications.
About VistaGen VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines with for multiple CNS diseases and disorders with high unmet need. Each of VistaGen’s CNS pipeline candidates has potential as a convenient, at-home treatment with rapid-onset therapeutic benefits and an exceptional safety profile – without psychological or other side effects and safety concerns often associated with current and potential new generation medications for certain highly-prevalent CNS diseases and disorders, such as major depressive disorder, neuropathic pain and social anxiety disorder. Each CNS drug candidate in VistaGen’s pipeline is either currently in, or has completed, Phase 2 clinical development. AV-101, an oral NMDA receptor glycine antagonist, is in Phase 2 development in the U.S. for treatment of MDD and in a first-step target engagement study in healthy volunteer U.S. military Veterans for suicidal ideation. The FDA has granted Fast Track designation for development of AV-101, both as a potential adjunctive treatment of MDD and as a non-opioid treatment for neuropathic pain. PH10 nasal spray is a potential first-in-class CNS neuroactive steroid with rapid onset effects observed at microgram doses and without systemic exposure. PH10 is in Phase 2 development for MDD. PH94B nasal spray also is a potential first-in-class CNS neuroactive steroid with rapid onset effects observed at microgram doses and without systemic exposure. Phase 2 development has been completed successfully, and PH94B is now being prepared for Phase 3 as an on-demand PRN treatment of Social Anxiety Disorder (SAD).