Vistagen announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration, FDA. The letter greenlights a U.S. Phase 1 clinical trial under Vistagen’s newly filed Investigational New Drug or IND application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder MDD. The small Phase 1 trial will involve the Company’s newly optimized formulation of PH10 and is intended to both 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, and facilitate Vistagen’s plans for Phase 2B development of PH10 as a stand-alone treatment for MDD. "People living with major depressive disorder urgently need new and differentiated therapies – we are committed to addressing that need. The FDA’s clearance to advance our clinical program for PH10 in the U.S. is another important milestone for our company," stated Shawn Singh, Chief Executive Officer of Vistagen. "With our newly optimized formulation and manufacturing process for PH10 in place, the FDA’s greenlight will now enable us to first confirm its favorable safety profile in a small Phase 1 study next quarter and then seek consensus with the FDA regarding our Phase 2B development plan for PH10 in major depressive disorder."
Published first on TheFly
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