After receiving a “Study May Proceed” letter from the FDA, Vistagen has announced plans for a Phase 1 trial of a re-formulated version of PH10 pherin nasal spray. The new Phase 1 study is expected to begin in early 2023 as part of plans to develop the nasal spray for the treatment of major depressive disorder. A previous Phase 2a trial of PH10 for that indication found that PH10 “could represent a useful treatment for MDD with a rapid onset of efficacy.”
Vistagen acquired the rights to PH10 from Pherin Pharmaceuticals in 2018; the company also acquired the rights to PH94B nasal spray from Pherin that same year. Vistagen recently announced that a Phase 3 trial of PH94B for the treatment of social anxiety disorder failed to meet its primary endpoint.
Vistagen CEO Shawn Singh commented, “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 US is another important milestone for our company. 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.”
Read the Vistagen press release.
