BioXcel Therapeutics, a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, announced completion of the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial. Topline data from the study are expected to be released this month and are intended to support the planned supplemental New Drug Application (sNDA) to potentially expand the label of IGALMI (dexmedetomidine) for use in the at-home (outpatient) setting.
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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 SERENITY At-Home study enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population. Distribution of patients was balanced between the two patient populations, bipolar disorders and schizophrenia.
“This marks a major milestone in our efforts to bring a much-needed at-home (outpatient) treatment option to the millions of individuals who experience agitation related to bipolar disorders or schizophrenia,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We’re grateful to the patients, caregivers, investigators, CRO, and our internal teams who made this possible in a very timely manner. With this final visit complete, we look forward to sharing topline results soon. This is another critical step toward advancing BXCL501 (IGALMI) as the first FDA-approved therapy for this indication in the home setting.”
There are an estimated 23 million episodes of bipolar or schizophrenia-related agitation annually in the U.S. that occur at home, and there are currently no FDA-approved therapies for acute treatment in this setting.
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About the SERENITY At-Home Phase 3 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 is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting.
About BXCL501
Outside of its approved indication by the U.S. Food and Drug Administration as IGALMIsublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics 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 safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA 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.
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