BXCL-504

BioXcel Therapeutics – still reeling from recent data integrity issues around a key study – announced that it will reduce its workforce from around 190 employees to 80 as part of a strategic overhaul. The company, whose shares were down 45% on Monday, said that moving forward it plans to focus on "high-potential agitation-market opportunities."CEO Vimal Mehta remarked "we are shifting our primary focus to development in the at-home setting while maintaining our value-creating core capabilities." The executive added "we intend to prioritise our resources to develop BXCL501 for use in assisted-living facility (ALF) and at-home settings, and continue to advance our neuroscience pipeline."In June, BioXcel reported that the Phase III TRANQUILITY II trial of BXCL501 - an investigational orally dissolving film formulation of dexmedetomidine - for the acute treatment of Alzheimer's disease-related agitation met its primary endpoint. However, the drugmaker's shares were hit after it emerged that a study investigator, who had enrolled approximately 40% of participants in the trial, was under scrutiny for fabricating email correspondence related to the timely reporting of a serious adverse event.BioXcel has engaged an independent third party to perform a data integrity audit of the affected TRANQUILITY II clinical site. The company has also requested a meeting with the FDA to discuss the results needed to support a marketing application for BXCL501 and whether a new study would be necessary. Meanwhile, the drugmaker noted that it has paused enrolment in the TRANQUILITY III trial, which is evaluating BXCL501 in patients in nursing homes with agitation associated with moderate-to-severe dementia with probable Alzheimer's disease.BXCL501 is also being developed for the treatment of agitation in schizophrenia and bipolar disorders, although studies in major depressive disorder will be shelved as part of its strategic reprioritisation. BioXcel's neuroscience pipeline also includes BXCL502, BXCL503 and BXCL504, while it continues to look at options for its immune-oncology subsidiary OnkosXcel Therapeutics.According to the company, the cost-cutting measures, which also include a shift in commercial strategy for Igalmi (dexmedetomidine) in the institutional setting, will reduce more than 50% of its cash burn. Igalmi is currently marketed in the US for the acute treatment of adults experiencing schizophrenia or bipolar I/II disorder-associated agitation, but must be administered under the supervision of a healthcare provider.