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BioXcel Therapeutics Announces Promising Topline Results from Part 1 of Pivotal SERENITY III Trial of BXCL501 for At-Home Use in Acute Treatment of Agitation in Bipolar Disorders or Schizophrenia
Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI™ Greater than 50% PEC response rate attained; proportionally
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI™ Greater than 50% PEC response rate attained; proportionally consistent with dose response when compared to rates seen in SERENITY I and II BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at-home use SERENITY III Part 2 planned as an adaptive trial design with 60mcg and 80mcg to potentially address agitation spectrum for patients at home Company to hold conference today at 8 a.m. ET NEW HAVEN, Conn., May 25, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced promising results for BXCL501, the Company’s proprietary, orally dissolving film of dexmedetomidine under investigation for the treatment of agitation, in Part 1 of its Phase 3 SERENITY III trial conducted in institutional settings for acute treatment of bipolar disorders- or schizophrenia-associated agitation. These results are expected to enable the initiation of Part 2 for at-home use. BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved. SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use. Part 1 was similar to SERENITY I and II in design and assessed the efficacy and safety of a 60mcg dose using the same primary and secondary endpoints with patients in a monitored medical setting, as surrogates for the home setting. Patients enrolled in Part I were expected to have a relatively higher level of agitation than the home-based patient population expected to be enrolled in Part 2. Patients in Part 1 were evaluated with half (60mcg) of the already-approved 120mcg dose (IGALMI™) to enhance safety for the targeted at-home setting. “We are pleased with the outcome and progression of our land-and-expand strategy, which we believe moves us closer to addressing up to an additional 23 million annual agitation episodes in bipolar disorder and schizophrenia patients in the at-home setting. This would potentially more than double our current market opportunity, if approved....