BioXcel Therapeutics (BTAI) Announces Clinical Prioritization and Update on BXCL501

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced its clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. The clinical prioritization is intended to optimize resource allocation and focus on the development of its lead neuroscience asset into potential new markets, while deprioritizing sales efforts for its approved drug IGALMI™ (dexmedetomidine) sublingual film. The Company plans to maintain IGALMI in the market without its current commercial infrastructure.

“We are prioritizing our late-stage clinical programs for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer’s disease and placing greater emphasis on advancing these trials,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We believe these programs represent attractive growth opportunities, and we look forward to focusing on these top-priority clinical development initiatives.”

Update on Late-Stage Clinical Programs for BXCL501

• SERENITY At-Home Pivotal Phase 3 trial: designed to evaluate the safety of a 120 mcg dose of BXCL501 (an approved dose of IGALMI) in the at-home setting for agitation associated with bipolar disorders or schizophrenia.
  • The Company announced initiation of the 200-patient SERENITY At-Home trial, with safety as the primary endpoint, on September 5, 2024.
• TRANQUILITY In-Care Pivotal Phase 3 Trial: designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia.
  • The Company submitted its protocol for the TRANQUILITY In-Care trial to the U.S. Food and Drug Administration (FDA) on September 5, 2024.

IGALMI Market Presence

• The Company plans to continue to supply IGALMI™ to current and future customers through existing distribution channels, without commercial support.

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