Vistagen Therapeutics Inc (NASDAQ:VTGN) entered an understanding with the US FDA to commence pivotal Phase 3 clinical study of PH94B to cure anxiety in people with SAD (social anxiety disorder). The company will include anxiety-provoking simulated speaking challenge (SSC) in a single laboratory in the Phase 3 clinical trial.
Phase 3 trial at 12 to 15 sites
Vistagen will conduct the Phase 3 clinical studies at 12 to 15 sites across North America. It is a placebo-controlled and double-blind and randomized study to investigate the efficacy and safety profile of PH94B in treating anxiety in patients with SAD.
Vistagen selected Dr. Michael Liebowitz as a principal investigator for the Phase 3 clinical studies. Michael is working as a professor at Columbia University for the discipline of Clinical Psychiatry.
Will enroll 182 adults
Vistagen will recruit around 182 adults suffering from SAD for the Phase 3 clinical trial of PH94B. The company submitted development and preliminary protocol plan under the CTAP (Coronavirus Treatment Acceleration Program) of the US FDA to cure AjDA (adjustment disorder with anxiety).
Vistagen’s PH94B will address anxiety-provoking stressors like anxiety, fear regarding safety and health, unemployment, economic loss, distance learning, social isolation, and civil unrest caused by the COVID-19 pandemic.
Vistagen is in discussions with the FDA to chalk out a plan for the Phase 2A clinical study in AjDA in New York City. The company already completed the preparations for this clinical trial.
Receives more than $17.5 million
Vistagen received over $17.5 million through the issue of common shares to the general public and upfront license payment of PH94B.
CEO of Vistagen, Shawn Singh, said the company achieved several milestones in Q1 2021. Some of the notable achievements include a positive impact on clinical development programs such as Phase 3 clinical trial of PH94B to treat social anxiety disorder. The company also entered an understanding with the FDA to design Phase 3 clinical trial for Ph94B to cure social anxiety disorders.
Vistagen narrowed the net loss to $3.5 million YoY in Q1 2021. It’s spending on R&D also declined significantly to $1.7 million. Also, G&A expenses dropped to $1.4 million. The company holds cash equivalents and cash of $1.5 million.