By Khushi Mandowara
(Reuters) – BioXcel Therapeutics said on Thursday its experimental drug to treat agitation related to Alzheimer’s disease met the main goal in a late-stage study, but the results were marred by concerns over data integrity at one of the trial sites.
The drug, named BXCL501, showed statistically significant reduction in acute agitation after two hours compared with 5.4 hours for patients who were given a placebo.
The drug also helped reduce agitation symptoms at 1 hour of the first episode of agitation, a key secondary goal, but it did not meet another key target of change in score at 30 minutes.
BioXcel said it plans submit an application to expand the use of the drug in the second half of this year.
It is already approved by the U.S. Food and Drug Administration for treating agitation associated with schizophrenia or bipolar I or II disorder in adults.
However, the company said it faced some issues related to documentation of the clinical study at one of its sites.
BioXcel said the principal investigator at the site was found to have fabricated email correspondence related to the timing of reporting serious side-effects to the company’s vendor responsible for monitoring safety of the drug so as to make it appear as though they had been reported in a timely manner as required by the trial protocol.
It is more of a documentation issue and not a fabrication of side-effects, said BioXcel CEO Vimal Mehta, adding the company may do its own independent audit to ensure integrity of the data.
The company plans to conduct an investigation related to the data integrity and protocol adherence, while the timing related to completion of trial remains unclear.
(Reporting by Khushi Mandowara in Bengaluru; Editing by Krishna Chandra Eluri)
