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BioXcel Therapeutics Announces Results of Phase 1b/2 Study of BXCL501 for the Treatment of Opioid Withdrawal Symptoms
Primary safety endpoint achieved in first study of BXCL501 dosed twice-daily over seven days RELEASE results demonstrated numerically improved retention rates
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Primary safety endpoint achieved in first study of BXCL501 dosed twice-daily over seven days RELEASE results demonstrated numerically improved retention rates in multiple BXCL501 dose cohorts Data from multiple dosing regimen in RELEASE supports investigation across additional indications and treatment settings NEW HAVEN, Conn., March 31, 2021 (GLOBE NEWSWIRE) -- 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 topline results from its Phase 1b/2 proof-of-concept RELEASE study of BXCL501, the Company’s proprietary, orally dissolving thin film formulation of dexmedetomidine, for the treatment of opioid withdrawal symptoms. The study met its primary safety endpoint across multiple doses given twice-daily over seven days. BXCL501 was generally well tolerated, with no severe or serious adverse events reported, and dose dependent exposures were observed across all doses evaluated (30 mcg, 60 mcg, 90 mcg, 120 mcg, 180 mcg and 240 mcg). See table below with focus on cardio-vascular and nervous system treatment emergent adverse events. System Organ Class Preferred TermBXCL501 30 mcg(N=17)n (%)BXCL501 60 mcg(N=17)n (%)BXCL501 90 mcg(N=21)n (%)BXCL501 120 mcg(N=19)n (%)BXCL501 180 mcg(N=21)n (%)BXCL501 240 mcg(N=15)n (%) Placebo(N=25)n (%)Cardiac disorders000001 (6.7)0Bradycardia000001 (6.7)0 Vascular disorders01 (5.9)002 (9.5)6 (40.0)0Hypotension01 (5.9)0005 (33.3)0Orthostatic hypotension00002 (9.5)4 (26.7)0 Nervous system disorders00003 (14.3)7 (46.7)0Dizziness00001 (4.8)00Presyncope000001 (6.7)0Somnolence00002 (9.5)7 (46.7)0 Treatment Emergent Adverse Events (\"TEAEs\") are adverse events with an onset date (and time) equal to or later than the first dose date (and time).Subjects are counted once within each system organ class and preferred term.Includes number of any TEAEs, and number (%) of subjects with any TEAEs.BXCL501 doses were administered BID (twice a day). With respect to retention, a secondary endpoint, the study showed that patients in multiple dose cohorts treated with BXCL501 had numerical improvements in retention rates, a key goal of opioid withdrawal treatment. The 120 mcg and 180 mcg dose groups showed 42% and 52% rates o...