Benzinga - by Vandana Singh, Benzinga Editor.
BioXcel Therapeutics Inc (NASDAQ: BTAI) announced alignment with the FDA's recommendation for a Phase 3 trial in the TRANQUILITY program of BXCL501 for acute treatment of agitation associated with Alzheimer's dementia.
The company aligned with the FDA's recommendation to conduct an additional Phase 3 trial of BXCL501 to evaluate safety and collect additional efficacy data in at-home setting.
- The planned study is expected to enroll approximately 100 patients aged 65 years and older with mild, moderate, or severe dementia who will self-administer 60 mcg of BXCL501 or a placebo whenever agitation episodes occur over four weeks.
- TRANQUILITY III trial is no longer required for potential supplemental marketing application submission. The company plans to explore a potential separate clinical development program for chronic agitation.
- Based on FDA feedback, BioXcel plans to conduct a Phase 3 trial with 120 mcg (Igalmi approved dose) to evaluate safety in at-home setting.
The company entered into a binding term sheet to restructure key financial terms in its agreements with Oaktree Capital Management and Qatar Investment Authority.
BioXcel estimates its current cash and cash equivalents will fund its operations through mid-2024.
Price Action: BTAI shares are down 24.10% at $4.18 on the last check Tuesday.
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