BioXcel announces plan for evaluating BXCL501 in at-home setting

BioXcel Therapeutics announced additional details regarding the planned design of its SERENITY At-Home Phase 3 trial*to evaluate BXCL501, the Company’s investigational, proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with bipolar disorders or schizophrenia in the home setting. The Company’s plan to conduct this trial using a 120 mcg dose is based on feedback received from the U.S. Food and Drug Administration following the recent receipt of agency minutes from the Type C meeting held on March 6, 2024. SERENITY At-Home Pivotal Phase 3 Trial Design Summary: The SERENITY At-Home Phase 3 trial is designed as a double blind, placebo-controlled study to evaluate the safety and efficacy of a 120 mcg dose of BXCL501 over a 12-week period. The outpatient trial is expected to enroll a total of approximately 200 patients with agitation associated with bipolar disorder or schizophrenia. Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the trial period. The primary objective is safety with efficacy measures as exploratory endpoints to evaluate use in the outpatient setting. In addition, the Company expects to enroll approximately 30 patients in a separate study to evaluate the correlation between patient-reported or informant-reported efficacy with trained rater-reported efficacy using Positive and Negative Syndrome Scale-Excitatory Component measurements.