BioXcel Therapeutics, Inc. has announced positive topline exploratory efficacy data from its SERENITY At-Home Pivotal Phase 3 safety trial, designed to evaluate the safety and efficacy of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in an at-home setting. The trial involved 246 patients and data collection on 2,628 agitation episodes over a 12-week period. The study demonstrated a significant mean reduction in the modified Clinical Global Impression-Severity score from baseline compared to placebo at 2 hours, indicating the potential efficacy of BXCL501 with repeat dosing. Complete resolution of agitation symptoms was significantly higher in the BXCL501 arm compared to placebo across varying levels of agitation severity. These findings underscore the potential benefits of BXCL501 in the outpatient setting. The results of this trial have already been presented.
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