BioXcel Therapeutics, Inc. (NASDAQ:BTAI) on Wednesday released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, which demonstrated that BXCL501 had continued effects and consistent benefit with repeat dosing.
The trial in the home setting evaluated a 120 mcg dose of BXCL501, the company’s proprietary, sublingual film formulation of dexmedetomidine, Igalmi, for agitation associated with bipolar disorders or schizophrenia.
Recently, BioXcel reported topline safety results and is reporting additional findings on Wednesday.
The data from the trial will form the basis of the sNDA submission for label expansion of Igalmi in the at-home setting planned for the first quarter of 2026.
Across 2,433 treated episodes in the trial, BXCL501 demonstrated a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours.
Patients experienced a complete resolution of agitation symptoms measured by mCGI-S at significantly higher rates with BXCL501 compared to placebo across the severity of agitation episodes, with an overall resolution of 50% in the BXCL501 arm, compared to 33% on placebo.
Severe agitation episodes fully resolved (no agitation) in 61% of episodes in the BXCL501 arm, compared to 18% on placebo.
Moderate agitation episodes fully resolved in 43% of cases for patients in the BXCL501 arm, compared to 34% on placebo.
Mild agitation episodes fully resolved in 60% of cases for patients in the BXCL501, compared to 40% on placebo.
Complete resolution of agitation was significantly higher with BXCL501 compared to placebo, regardless of agitation episode severity.
There was a mean reduction in mCGI-S score of 1.2 following the first 12 doses and a mean reduction of 1.4 following 13 or more doses of BXCL501.
Igalmi is currently FDA-approved and marketed for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings.
BTAI Price Action: BioXcel Therapeutics shares were up 3.07% at $3.69 at the time of publication on Wednesday. The stock is trading within its 52-week range of $1.17 to $13.36, according to Benzinga Pro data.
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