BioXcel Schedules KOL Roundtable on 100M Alzheimer’s Agitation Episodes, BXCL501 Phase 3

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BioXcel Therapeutics will host a virtual KOL roundtable on February 27 to discuss acute agitation in Alzheimer’s dementia, affecting approximately 100 million episodes annually and lacking FDA-approved therapies. The panel will evaluate the potential of late-stage candidate BXCL501 and outline preparations for the 200-patient TRANQUILITY In-Care Phase 3 trial assessing a 60 mcg dose over 12 weeks.

1. Virtual KOL Roundtable

BioXcel Therapeutics will host a virtual key opinion leader roundtable on February 27 from 2:00 to 3:00 p.m. EST, featuring three leading medical experts in geriatric psychiatry and neurology. The session aims to raise awareness of acute agitation episodes in Alzheimer’s dementia and engage stakeholders on potential treatment strategies.

2. Unmet Need in Alzheimer’s Agitation

Acute agitation episodes in Alzheimer’s dementia impact an estimated 100 million occurrences annually, with no FDA-approved therapies available for this patient population. These episodes pose significant challenges in care settings such as skilled nursing facilities, memory care units and assisted living communities.

3. BXCL501 and TRANQUILITY In-Care Trial

Panelists will explore the differentiated profile of late-stage candidate BXCL501, an investigational orally dissolving dexmedetomidine film. BioXcel is advancing preparations for the TRANQUILITY In-Care Phase 3 trial, a randomized, double-blind, placebo-controlled study enrolling 200 patients aged 55 and older to assess a 60 mcg dose over 12 weeks with PEC total score as the primary endpoint.

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