BioXcel's BXCL501 Lower Dose Shows Statistical Significance On Agitation Scales

BioXcel Therapeutics Inc (NASDAQ: BTAI) plans to finalize study design, dosing, and endpoints for its BXCL501 Phase 3 program in dementia-related agitation. The end of the Phase 2 meeting with the FDA is scheduled in Q2 2021.

• BXCL501 is an orally dissolving thin film formulation of dexmedetomidine (Dex).
• In January, the company announced data from the TRANQUILITY Phase 1b/2 study in dementia-related agitation. 
• 60 mcg dose of BXCL501 met the primary and all secondary endpoints, demonstrating statistically significant, clinically meaningful, rapid, and durable reductions in agitation with no severe or serious adverse events.
• A lower 30 mcg dose showed numerical improvements compared to the placebo.
• Following a routine review of TRANQUILITY study data, the company discovered that two patients were miscategorized within the 30 mcg cohort.
• After moving the two patients into their appropriate placebo and 30 mcg groups, the data from the 30 mcg cohort were re-analyzed, resulting in the 30 mcg dose crossing over to statistical significance at the two-hour time point on agitation score.
• Additionally, BioXcel has initiated a 46-patient study to evaluate a 40 mcg dose cohort of BXCL501. 
• Price Action: BTAI shares are down 4.5% at $50.34 on the last check Wednesday.