Phase 3 Trial of Dexmedetomidine for Bipolar I or II, Schizophrenia Doses First Participants

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The first 13 participants have been dosed in part 1 of the phase 3 SERENITY III trial investigating at-home use of dexmedetomidine (BXCL501) sublingual film for agitation associated with bipolar I or II disorder or schizophrenia.

“Evaluating BXCL501 for at-home use is an exciting and important milestone that potentially expands the market opportunity for the treatment of agitation,” said Robert Risinger, MD, Chief Medical Officer of Neuroscience at BioXcel Therapeutics.¹

SERENITY III is a 2-part, double-blinded, placebo-controlled study to evaluate BXCL501 60 mcg dose for at-home use. The first part of the study, similar to SERENITY I and II, is designed to determine the efficacy and safety of a 60 mcg dose in acutely agitated patients with bipolar disorder or schizophrenia in a monitored setting. The primary efficacy endpoint is the change from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at 2 hours after dosing compared to placebo.

Approximately 200 participants will be enrolled in part 1 at up to approximately 20 clinical sites in the United States. Part 2 of the study will assess the safety of 60 mcg dose compared to placebo when self-administered at home.

BXCL501 has been granted breakthrough therapy designation for the acute treatment of agitation associated with dementia and fast track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

“We anticipate top-line data from SERENITY III as well as our TRANQUILITY II trial for Alzheimer’s-related agitation in the first half of 2023. These 2 near-term pivotal data readouts further reinforce the potential of BXCL501 to address the unmet medical needs of millions of patients,” said Risinger.¹

Reference

1. BioXcel Therapeutics announces first patients dosed in SERENITY III phase 3 trial for acute treatment of agitation in adults with bipolar I or II disorder or schizophrenia. BioXcel Theerapeutics. News release. November 30, 2022. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-first-patients-dosed-serenity-iii