BioXcel announces positive findings from independent third party audit

BioXcel Therapeutics announced positive findings from an independent third party audit of the data from a single site in its TRANQUILITY II Phase 3 trial. Conducted by a well-regarded regulatory and quality consulting firm, the independent audit consisted of a comprehensive review of records from over 50% of subjects enrolled at the single trial site to identify any additional instance of misconduct or fraud and to evaluate data integrity and reliability for eligibility, safety, and efficacy data. This sample size provides 95% confidence that the data reviewed is a representative sample. Following an extensive review, the team of auditors did not identify any findings that they believe impact the data reliability or integrity, nor did they find any evidence of additional misconduct or fraud. Based on these findings, BioXcel Therapeutics believes that the positive, statistically significant TRANQUILITY II trial data announced in June 2023 potentially support a supplemental new drug application for BXCL501 for the acute treatment of agitation associated with dementia in probable Alzheimer’s disease.