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Vistagen Poised To Begin Phase 1 Trial Of A Fast-Acting Antidepressant Nasal Spray In First Quarter Of 2023
--News Direct--By Rachael Green, BenzingaIn the race to create faster-acting, safer antidepressants, Vistagen (NASDAQ: VTGN) is starting the year strong as it
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"--News Direct--By Rachael Green, BenzingaIn the race to create faster-acting, safer antidepressants, Vistagen (NASDAQ: VTGN) is starting the year strong as it gets ready to launch a Phase 1 Trial of its novel pherine nasal spray for Major Depressive Disorder (MDD). The trial, involving the Company’s newly optimized formulation of PH10, is intended to confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD. After receiving a “study may proceed” letter from the U.S. Food and Drug Administration (FDA) last November followed by a Fast-Track designation from the FDA in December, the late clinical-stage biopharmaceutical company is ready to start the Phase 1 trial in the first quarter of 2023. Upcoming Phase 1 Clinical Trial Will Prepare Vistagen’s Drug Candidate PH10 for Phase 2B ResearchOn November 30, Vistagen announced that it had received a “study may proceed” letter from the FDA for PH10 as a treatment for MDD. The following week, the FDA granted Fast-Track designation to the pherine-based nasal spray. The FDA’s fast track program, meant to bring promising new treatments for serious conditions to patients sooner, makes Vistagen’s drug eligible for more frequent meetings and communications with the FDA – which can help ensure a smoother development and review process and, potentially, an earlier drug approval date.The FDA’s decision to grant Fast-Track designation was based on Vistagen’s previous preclinical and clinical research on PH10. In an earlier Phase 2A study of PH10, for example, the MDD treatment was found to significantly reduce depressive symptoms in participants after only one week of treatment and at the eight-week study endpoint. The upcoming Phase 1 study will enroll 12 participants in a double-blind, placebo-controlled clinical trial with topline data expected by the end of the first quarter. The goal of the study is to confirm the favorable safety data demonstrated in earlier clinical trials and lay the groundwork for a Phase 2B study of PH10 in MDD.On December 21, Vistagen announced its acquisition of Pherin Pharmaceuticals, a clinical-stage company developing a pipeline of pherine drug candidates. The acquisition will give Vistagen full ownership of the intellectual property rights for both PH...