BioXcel Therapeutics Completes SERENITY At-Home Pivotal Phase 3 Trial Database Lock

BioXcel Therapeutics has completed the database lock for its SERENITY At-Home pivotal Phase 3 safety trial for the acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results are expected in August. The trial collected data from over 2,600 agitation episodes and the company is thrilled to have reached this milestone efficiently. CEO Vimal Mehta expresses gratitude to the clinical team and all involved parties.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, has announced the completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial. The trial, evaluating the safety of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia, has reached a critical milestone in its development pathway.

The database lock, which freezes the clinical trial database and prevents further modifications before statistical analysis begins, signifies that the trial is ready for topline data readout. Topline results are expected in August, according to the company. The trial collected data from over 2,600 agitation episodes across more than 200 patients, providing a substantial safety dataset.

BioXcel's CEO, Vimal Mehta, Ph.D., expressed gratitude to the clinical team, patients, principal investigators, and all involved parties for their dedication and collaborative efforts. He noted that the completion of the database lock is a significant step forward in the efficient progression of the trial.

The SERENITY At-Home Phase 3 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 associated with bipolar disorders or schizophrenia in the at-home setting. The trial was conducted across 22 sites nationwide and enrolled patients with a history of agitation episodes despite being on stable treatment for their underlying conditions.

BXCL501, an investigational proprietary, orally dissolving film formulation of dexmedetomidine, is currently under investigation for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The company has received Fast Track Designation for BXCL501, addressing an unmet need as there are currently no FDA-approved therapies for acute agitation treatment in at-home settings.

The trial's balanced enrollment between bipolar disorder and schizophrenia populations is methodologically sound, as agitation presents differently across these conditions. The collection of data from over 2,600 agitation episodes is particularly valuable, as it likely captures the heterogeneous nature of these events. This comprehensive dataset should provide insights into real-world effectiveness across different episode characteristics, though the press release does not specify the primary safety endpoints being measured.

BioXcel Therapeutics' methodical approach to the trial, including multiple oversight mechanisms such as Data Safety Monitoring Board reviews, sponsor eligibility verification, and independent GCP compliance checks, aligns with the expectations for a pivotal safety trial intended to support regulatory approval. If positive, these results could complete the safety package needed for FDA submission, potentially positioning BXCL501 as a first-in-class treatment for this indication in the outpatient setting.

References:
[1] https://www.stocktitan.net/news/BTAI/bio-xcel-therapeutics-announces-database-lock-in-serenity-at-home-ru2yybe631sw.html