Shares of San Francisco-based biotech VistaGen (NASDAQ: VTGN) experienced a dramatic increase of over 600% by the end of trading yesterday, following the release of positive topline Phase III data for fasedienol, a novel rapid-onset nasal spray treatment for social anxiety disorder (SAD). The PALISADE-2 study demonstrated that fasedienol achieved significant improvement in the primary endpoint, positioning it to become the first new treatment for SAD in 15 years.
Fasedienol’s Efficacy in Treating Social Anxiety Disorder
The trial, which assessed the safety and efficacy of fasedienol (PH94B) nasal spray in adults diagnosed with SAD, showed a significant improvement in the primary endpoint of patient-reported Subjective Units of Distress Scale (SUDS) score compared to placebo during a public speaking challenge (primary endpoint, p=0.015). The secondary endpoint was also met, with a significant difference in the proportion of clinician-assessed responders for fasedienol versus placebo.
Fasedienol’s Mechanism of Action and Market Potential
Fasedienol is a first-in-class, rapid-onset pherine nasal spray that allows microgram doses to be administered intranasally. Pherines, odorless synthetic neuroactive steroids, bind to distinct receptors on chemosensory cells in the nasal passages, impacting the limbic amygdala without systemic uptake, with onset occurring in approximately 15 minutes. The firm’s share price surged over 1,000% at one point during trading, closing at a 677% growth, reflecting the highly differentiated mechanism of action of VistaGen compared to traditional SAD treatments such as benzodiazepines and beta blockers.
Fasedienol’s Development in China and Asia
VistaGen’s product is already under development for the China market under a 2020 deal signed with Chinese firm EverInsight Therapeutics Inc., which later merged into Affamed Therapeutics. EverInsight made a USD 5 million upfront payment alongside USD 172 million in potential milestones for development and commercial rights to the drug in China, Korea, and South-East Asia. Affamed announced the initiation of the China arm of the PALISADE trial in April 2022.-Fineline Info & Tech
