BioXcel Therapeutics provides update on recent developments for IGALMI

BioXcel Therapeutics provided an update on recent developments with its late-stage clinical programs as well as its patent portfolio for IGALMI sublingual film. These developments include meetings scheduled with the U.S. Food and Drug Administration to discuss the TRANQUILITY and SERENITY III clinical programs and the receipt of two Notices of Allowance from the U.S. Patent and Trademark Office to extend method of use patent protection for sublingual dexmedetomidine. Agitation Associated with Mild to Moderate Dementia due to Probable Alzheimer’s Disease: Type B/Breakthrough Meeting on October 11: The Company plans to review its TRANQUILITY clinical trial program with the FDA and to discuss the data package required to support submission of an sNDA for the approval of BXC501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer’s disease in assisted living facilities and at-home settings. The briefing book submitted to FDA for the meeting includes results from 11 double-blind, placebo-controlled Phase 2 and 3 clinical trials evaluating the safety and efficacy of BXCL501. Of the subjects who received various doses of BXCL501, 273 were over 60 years of age, and 204 were over 65 years of age. Data from TRANQUILITY I led the FDA to grant BXCL501 Breakthrough Therapy designation for the acute treatment of agitation associated with dementia. Additionally, the efficacy results seen in TRANQUILITY II after 12 weeks for all treated episodes was comparable to those observed after the first dose. At-Home Setting in Agitation Associated with Bipolar Disorders I and II and Schizophrenia: The Company will review its SERENITY III program with the FDA on November 8, 2023 and plans to discuss the data package required to support submission of an sNDA seeking approval of BXCL501 for the acute treatment of agitation associated with bipolar disorders I and II and schizophrenia in the at-home setting. The primary objective of Part 2 of SERENITY III is to assess safety, and the secondary objectives include various efficacy assessments. IGALMI Market Exclusivity Strengthened: Two Notices of Allowance Received: BioXcel Therapeutics recently received two NOAs from the U.S. Patent and Trademark Office for patent applications related to the method of use of sublingual dexmedetomidine for the treatment of agitation associated with bipolar disorders and schizophrenia. The Company now has four U.S. patents claiming formulations of dexmedetomidine with exclusivity until 2039 currently listed in the Orange Book. The Company expects that these two new patents will expire no earlier than Dec. 29, 2037, subject to the patent term adjustment, patent term extension, and terminal disclaimers.