BioXcel Therapeutics Reaches 33% Enrollment in SERENITY At-Home Trial
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), based in New Haven, has announced that its SERENITY At-Home clinical trial has successfully achieved 33% enrollment, with 67 patients recruited so far. This significant milestone is part of the pivotal Phase 3 trial assessing the safety of BXCL501, an investigational oral film formulation of dexmedetomidine, designed specifically for the at-home management of agitation associated with bipolar disorders or schizophrenia.
Trial Objectives and Progress
The SERENITY At-Home trial is crucial for the potential expansion of the label for BioXcel's FDA-approved IGALMI® (dexmedetomidine) sublingual film. As noted by Vimal Mehta, Ph.D., the CEO of BioXcel Therapeutics, the trial is being conducted at multiple sites, with a focus on using the lowest approved dose of IGALMI, which stands at 120 mcg. The primary objective of the trial is patient safety, ensuring that the treatment can be administered effectively in a familiar environment.
Overview of the SERENITY At-Home Trial
This double-blinded, placebo-controlled trial aims to enroll a total of 200 patients. Participants will self-administer either BXCL501 or a placebo during episodes of agitation over a 12-week period. The study is gathering safety data meticulously, with a Data Safety Monitoring Board set to evaluate the safety and efficacy throughout the trial.
Significance of the Trial
The necessity for safe and effective treatments for agitation episodes, particularly in the home setting, is profound. Annually, there are around 23 million episodes reported within the U.S. alone, but currently, there are no FDA-approved options catering to this critical need. Therefore, the SERENITY trial represents a vital step toward addressing this treatment gap.
Expectations and Future Goals
While topline data results are anticipated in the latter part of 2025, BioXcel is focused on maintaining the momentum in patient enrollment and completing the trial efficiently. This will help pave the way for a potential supplemental new drug application (sNDA) to expand the use of IGALMI beyond its current approved indications.
About BXCL501
BXCL501 positions itself as a transformative treatment option not only for patients dealing with bipolar disorders and schizophrenia but also for those suffering from agitation due to Alzheimer's dementia. This investigational formulation is expected to redefine treatment protocols, bringing hope to patients and families affected by these conditions.
Contacting BioXcel Therapeutics for More Information
For more details about BioXcel Therapeutics, Inc. or the SERENITY At-Home trial, interested parties can reach out through the company’s contact resources. Direct inquiries can be made via phone at 1-833-201-1088 or via email at medinfo@bioxceltherapeutics.com. Investors and stakeholders can stay informed by visiting bioxceltherapeutics.com.
Frequently Asked Questions
What is the SERENITY At-Home trial about?
The SERENITY At-Home trial assesses the safety of BXCL501 for treating agitation in bipolar disorders and schizophrenia, specifically in home settings.
How many patients are involved in the trial?
The trial aims to enroll a total of 200 patients, and currently, 67 patients have been enrolled.
What is BXCL501?
BXCL501 is a proprietary, orally dissolving film formulation of dexmedetomidine, being investigated for the acute treatment of agitation associated with various psychiatric conditions.
When is the topline data expected?
Topline data from the SERENITY At-Home trial is expected in the latter half of 2025.
How can I learn more about BioXcel Therapeutics?
For more information, visit bioxceltherapeutics.com or contact them directly through the provided communication channels.
