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BioXcel Therapeutics Announces Positive Findings from Independent Third Party Audit of Data Integrity at TRANQUILITY II Phase 3 Trial Site
No evidence of misconduct or fraud found beyond instance previously reported1 No findings identified that impact data integrity Company believes audit
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"No evidence of misconduct or fraud found beyond instance previously reported1 No findings identified that impact data integrity Company believes audit findings support reliability of positive TRANQUILITY II trial data and potential sNDA submission NEW HAVEN, Conn., Oct. 25, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced positive findings from an independent third party audit of the data from a single site1 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 fraud2 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 (sNDA) for BXCL501 for the acute treatment of agitation associated with dementia in probable Alzheimer’s disease. “We believe these results of an audit by a respected, independent firm validate the integrity of data from the single site in question and add to the body of clinical evidence we intend to include in our sNDA submission,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We recently had a Type B/Breakthrough meeting with the FDA to discuss our plans for the development of BXCL501 for the acute treatment of agitation associated with dementia in probable Alzheimer’s disease. We expect to receive the FDA meeting minutes in the first half of November, and intend to provide an update on additional steps for the TRANQUILITY program and a potential sNDA in our upcoming third quarter financial results.” About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceut...