Benzinga | Feb 25, 2021 07:11AM EST

BioXcel Therapeutics Announces Initiation of Phase 2 PLACIDITY Trial of BXCL501 for the Treatment of Delirium Related Agitation

BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the initiation of the Phase 2 PLACIDITY trial of BXCL501, the Company's investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine ("Dex"), for the treatment of delirium related agitation.

"The initiation of PLACIDITY marks an important milestone in our efforts to showcase BXCL501's ability to calm patients struggling with delirium related agitation, our fifth potential indication for this candidate," commented Vimal Mehta, Chief Executive Officer of BioXcel. "Treating agitation associated with delirium remains a challenge for healthcare workers and patients as there are no FDA-approved therapies and off-label treatments are suboptimal, resulting in serious medical complications and extended hospital stays. We believe BXCL501, if approved, would be a welcomed therapy option for the approximately 4 million U.S. patients suffering from delirium related agitation annually, and we look forward to reporting topline results in the first quarter of 2022. Moreover, since delirium occurs across treatment settings within a hospital, this potential indication would be synergistic with the commercial infrastructure we are currently building to support our first New Drug Application."

The PLACIDITY trial is a multicenter, randomized, double-blind, placebo-controlled, ascending dose-finding, adaptive Phase 2 study designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium related agitation, including COVID-19 patients. Approximately 20 patients will be randomized into each sequential ascending dose cohort of BXCL501 (starting doses of 120 ug, 180 ug, 240 ug, or 300 ug), or matching placebos to determine an optimal starting dose that could effectively and safely reduce agitation. Elderly delirium patients (65 years or older) in these cohorts will receive half the dose. The primary endpoint is the reduction in agitation measured by at least a 2-point drop in the Richmond Agitation Sedation Scale ("RASS") at two hours post BXCL501 administration. The secondary endpoint is the earliest time at which a 2-point drop is seen in RASS after BXCL501 administration. An exploratory endpoint of this trial will be to determine the overall clinical improvement after drug administration using the Clinical Global Impression -- Improvement Scale ("CGI-I").