BioXcel Therapeutics Completes Database Lock for SERENITY Phase 3 Trial

BioXcel Therapeutics has completed database lock for its SERENITY Phase 3 trial, evaluating BXCL501 for acute agitation treatment in bipolar disorders and schizophrenia patients. Over 2,600 agitation episodes were collected from over 200 patients. BXCL501 has received Fast Track Designation from the FDA, and topline results are expected later this month.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has completed the database lock for its SERENITY Phase 3 trial, a pivotal safety study evaluating the acute treatment of agitation associated with bipolar disorders and schizophrenia using BXCL501. The trial, which enrolled over 200 patients across 22 sites nationwide, has collected data from more than 2,600 agitation episodes [1].

The SERENITY At-Home trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation in the at-home setting. The trial enrolled patients with a history of agitation episodes despite stable treatment for their underlying conditions. Participants were required to self-administer BXCL501 or placebo when they experienced agitation episodes over the 12-week trial period, with safety data and exploratory endpoints collected [1].

The completion of the database lock signifies a significant milestone for BioXcel Therapeutics, as it paves the way for the analysis and reporting of topline results. Topline results from the SERENITY At-Home trial are expected in August, following the completion of the database lock [1].

BXCL501, an investigational proprietary, orally dissolving film formulation of dexmedetomidine, has received Fast Track Designation from the FDA for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The drug has also been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia [1].

About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The company's drug re-innovation approach leverages existing approved drugs and clinically validated product candidates, combined with big data and proprietary machine learning algorithms, to identify new therapeutic indications [1].

References:
[1] https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-database-lock-serenity-home