BioXcel Completes Last Patient Visit in SERENITY Trial for Acute Agitation Treatment

BioXcel Therapeutics has completed its pivotal Phase 3 SERENITY At-Home trial for IGALMI, a treatment for agitation in patients with bipolar disorders or schizophrenia. The study included over 200 patients and 2,200 episodes of agitation. Topline results are expected later this month, with a potential FDA approval for at-home use. If approved, IGALMI would be the first FDA-approved therapy for at-home use in the U.S., addressing a significant unmet need.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has completed the last patient last visit (LPLV) in its pivotal Phase 3 SERENITY At-Home clinical trial, a significant milestone in the company's efforts to develop a transformative medicine for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial, designed to evaluate the safety of a 120 mcg dose of BXCL501 (IGALMI®), enrolled over 200 patients across 22 sites nationwide. Topline data from the study are expected to be released this month, potentially supporting a supplemental New Drug Application (sNDA) to expand the label of IGALMI for at-home use [1].

The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study that collected data from more than 2,200 agitation episodes. The trial enrolled patients with a history of agitation episodes residing at home, either alone or with caregivers/informants. Participants self-administered 120 mcg of BXCL501 or placebo when agitation episodes occurred over the 12-week trial period. The study also included exploratory endpoints to evaluate the use of BXCL501 in the outpatient setting [1].

Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, expressed gratitude to the patients, caregivers, investigators, CRO, and internal teams for their contributions. "This marks a major milestone in our efforts to bring a much-needed at-home treatment option to the millions of individuals who experience agitation related to bipolar disorders or schizophrenia," Mehta said [1].

IGALMI (dexmedetomidine) sublingual film is currently approved for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. However, there are no FDA-approved therapies for acute treatment in the at-home setting. The SERENITY At-Home trial aims to address this unmet need by evaluating the safety and efficacy of BXCL501 in a real-world setting [1].

If approved, IGALMI would be the first FDA-approved therapy for at-home use in the U.S., addressing a significant unmet need. The safety and efficacy of BXCL501 for this indication have not been established, and further clinical trials are needed to confirm its effectiveness [1].

References:
[1] https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-last-patient-last-visit-serenity