VTGN - Vistagen up 17% after Phase 3 data for anxiety candidate

2023-03-22 11:13:40 ET

VistaGen Therapeutics ( NASDAQ: VTGN ) jumped ~17% on Wednesday morning after announcing data from a Phase 3 trial for its experimental nasal spray for social anxiety disorder (SAD), fasedienol (PH94B), in adults.

As for its primary endpoint, the treatment was found to be safe and well tolerated in adults with SAD following long-term administration at a 3.2 µg dose up to four times a day, as needed, according to the company.

Out of 481 patients in the safety population, 56.8% of subjects have experienced at least one treatment-emergent adverse event, including 1.9% and 54.9% who reported severe and mild to moderate TEAEs, respectively.

Headache was the comments TEAE impacting 17% of the group, and 2.9% of patients who developed a TEAE dropped out of the study.

The company said there was a clinically meaningful functional improvement for a measure designed to assess a SAD patient's response to an anxiety-triggering event which was the trial's secondary endpoint .

That measure, known as Liebowitz Social Anxiety Scale (LSAS), has been selected by the company as the primary efficacy outcome measure to support the late-stage development of PH94B towards a marketing application.

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