Vistagen has announced the initiation of a Phase 1 clinical trial of its PH10 pherine nasal spray, which the company is developing for the treatment of major depressive disorder. In November 2022, the company announced that it had gotten the go-ahead for the Phase 1 trial of a new formulation of PH10 from the FDA, and the agency granted Fast Track designation to PH10 in December 2022. Topline results from the study are expected to be available by the middle of 2023.
Since 2018, Vistagen has been developing two pherine-based nasal sprays, PH10 and PH94B, that it licensed from Pherin Pharmaceuticals. In December 2022, Vistagen announced that it had reached an agreement to acquire Pherin and Pherin’s entire pipeline.
Vistagen CEO Shawn Singh said, “The initiation of this US Phase 1 study of Vistagen’s novel pherine nasal spray, PH10, represents a major milestone for our team as well as for the millions of individuals left struggling with major depressive disorder. We expect this Phase 1 trial to augment our record of favorable safety and tolerability data for PH10 across all prior clinical studies. Upon completion of the study and subsequent data readout, we will seek feedback from the FDA regarding potential Phase 2B development of PH10 as a stand-alone treatment for major depressive disorder, building on past success in the Phase 2A clinical program.”
Read the Vistagen press release.
