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BioXcel Therapeutics Announces First Patient Enrolled in Phase 1b/2 RELEASE Trial of BXCL501 for the Treatment of Opioid Withdrawal Symptoms
Topline results expected in the first quarter of 2021 NEW HAVEN, Conn., June 11, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”)
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Topline results expected in the first quarter of 2021\nNEW HAVEN, Conn., June 11, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that the first patient has been enrolled in the Phase 1b/2 RELEASE trial of BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”), for the treatment of opioid withdrawal symptoms.\n “The initiation of the RELEASE trial is a major milestone for our neuroscience program, as we believe it not only showcases BXCL501’s promise across multiple indications, but also supports this candidate’s potential as a sub-chronic treatment,” commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. “As the leading cause of death in the U.S. for individuals under the age of 50 years old, opioid abuse is a widespread problem that has been heightened by the COVID-19 pandemic. In order to avoid the painful symptoms associated with opioid withdrawal, individuals often continue to abuse these drugs or relapse, highlighting the need for better treatments to halt the cycle of addiction. After witnessing promising results with intravenous Dex, we believe BXCL501 may offer advantages over the current standard of care, as well as provide patients with a non-opioid therapy to alleviate the physiological symptoms of withdrawal. We look forward to reporting topline results from the study in the first quarter of 2021.” The RELEASE trial is a multicenter, randomized, double-blind, placebo-controlled, ascending-dose Phase 1b/2 study designed to evaluate the safety, pharmacokinetics, tolerability and efficacy of BXCL501 in patients experiencing symptoms of opioid withdrawal. This study will enroll approximately 125 subjects with opioid use disorder who are physically dependent on opioids. During the 7-day treatment phase, BXCL501 will be evaluated in sequential, ascending dose cohorts of 30ug, 60ug, 90ug, 120ug, and 180ug, administered twice daily (BID), approximately 12 hours apart. The study will assess opioid withdrawal symptoms using both the Clinical Opiate Withdrawal Scale (COWS) and Short Opiate Withdrawal Scale of Gossop (SOWS-GOSSOP) over a 10-day period. About BXCL501 BXCL501 is a pote...