BioXcel Therapeutics (BTAI) announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial. The results, along with the data from the SERENITY At-Home trial, will be included in the supplemental New Drug Application, sNDA, submission that is planned for the first quarter of 2026. The standard method for measuring acute agitation associated with schizophrenia and bipolar disorder is the Positive and Negative Syndrome Scale – Excited Component, PEC, administered by a trained clinician, which was used in the Serenity I & II Pivotal Trials. The study assessed the correlation between PEC and mCGI-S in this prospective, open label, in-clinic trial in 33 patients. The results demonstrated a strong correlation between the clinician assessments and the patient or caregiver rated outcomes, providing support for using mCGI-S to assess efficacy in the outpatient setting. A statistically significant and strong correlation between the PEC and mCGI-S was observed.
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