First participants dosed in phase 1 study of nasal spray for treatment of MDD

A biopharmaceutical company announced the first participants have been dosed in its phase 1 clinical trial of PH10, an investigational pherine nasal spray to treat major depressive disorder.

According to a release from Vistagen, the objective of its planned single-center, randomized, double-blinded, placebo-controlled phase 1 study is to investigate the safety and tolerability of PH10 in 12 healthy adult subjects.

The clinical trial is also intended to confirm the favorable safety profile of PH10 previously established in three prior clinical studies conducted in Mexico, including a published phase 2A study for the treatment of MDD, Vistagen said in the release.

“We expect this phase 1 trial to augment our record of favorable safety and tolerability data for PH10 across all prior clinical studies,” Shawn Singh, CEO of Vistagen, said in the release. “Upon completion of this study and subsequent data readout, we will seek feedback from the FDA regarding potential phase 2B development of PH10 as a standalone treatment for major depressive disorder, building on past success in the phase 2A clinical program.”

The company anticipates completing the study by the end of the first quarter this year, with topline results expected before the end of the first half of 2023.