BioXcel Therapeutics saw a significant increase in its stock price before the market opened on Wednesday, following the announcement of a positive independent audit of data from a late-stage trial. This audit not only supports the study data but also opens the possibility of submitting a supplementary new drug application.
After closing the previous session at $2.34, down 89% for the year, BioXcel shares surged by 36% in premarket trading.
The audit was conducted by a regulatory and quality consulting firm, which thoroughly reviewed records pertaining to more than half of the subjects involved in the single-site Phase 3 trial for BioXcel’s potential acute treatment of Alzheimer’s disease-related agitation. The company had already disclosed some instances of misconduct or fraud, but the auditors did not find any additional evidence of such behavior. Furthermore, they found no issues that might impact the reliability or integrity of the trial data.
These findings confirm the integrity of the data collected at the trial site and further solidify the clinical evidence that BioXcel plans to include in its new drug application. Vimal Mehta, the Chief Executive Officer, emphasized the importance of these results.
Additionally, BioXcel recently held a Type B breakthrough meeting with the U.S. Food and Drug Administration to discuss the development plans for BXCL501. The meeting minutes are expected to be released in early November.
In June, BioXcel announced positive topline results from its study on an orally dissolving formulation of dexmedetomidine. However, it later discovered that a principal trial investigator had fabricated email correspondence. In December of last year, the FDA conducted an inspection of a clinical trial site and discovered several issues, including the principal investigator’s failure to inform the sponsor’s medical monitor or pharmacovigilance safety vendor about a serious adverse event within the prescribed 24-hour timeframe.