BioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy Outcomes

Core Insights - BioXcel Therapeutics has completed clinical trials necessary for a supplemental New Drug Application (sNDA) submission, which is planned for the first quarter of 2026 [1] - The company reported positive results from the SERENITY At-Home trial, indicating a strong correlation between clinician assessments and patient/caregiver-rated outcomes [3][4] Group 1: Clinical Trial Results - The SERENITY At-Home trial showed a statistically significant correlation between the Positive and Negative Syndrome Scale – Excited Component (PEC) and the modified Clinical Global Impression – Severity Scale (mCGI-S), with correlation coefficients of ρ=0.89 for patients and ρ=0.88 for informants, both with p<0.0001 [3] - The mCGI-S scale was developed in consultation with the FDA to allow patients and caregivers to assess efficacy in an outpatient setting [2][6] Group 2: Safety and Efficacy - No serious adverse events were reported during the trials, and the safety profile of BXCL501 remains consistent with the existing IGALMI label [4] - BXCL501 is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders in the at-home setting, with Breakthrough Therapy and Fast Track designations from the FDA [8] Group 3: Future Plans - The findings from the SERENITY At-Home study will be included in the upcoming sNDA package [4] - Additional data and results from the trials are expected to be presented at future medical meetings and conferences [5]