BioXcel Therapeutics (BTAI) Announces Results of Phase 1b/2 Study of BXCL501 for the Treatment of Opioid Withdrawal Symptoms

March 31, 2021 4:03 PM EDT
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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)0
Bradycardia000001 (6.7)0
Vascular disorders01 (5.9)002 (9.5)6 (40.0)0
Hypotension01 (5.9)0005 (33.3)0
Orthostatic hypotension00002 (9.5)4 (26.7)0
Nervous system disorders00003 (14.3)7 (46.7)0
Dizziness00001 (4.8)00
Presyncope000001 (6.7)0
Somnolence00002 (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 of retention at Day 6 of BXCL501 treatment, respectively, versus 24% for placebo, though observations were not statistically significant. The results also showed that of the 87% of patients who had fentanyl in their systems upon entry, greater than 50% remained fentanyl positive following the morphine stabilization phase of 5 days. Consequently, withdrawal symptoms were not equivalent across various dose cohorts indicating morphine did not normalize withdrawal symptoms. Improvements were not observed in the severity of opiate withdrawal as measured by the Short Opiate Withdrawal Scale of Gossop (“SOWS-Gossop”) or the Clinical Opiate Withdrawal Scale (“COWS”). The Company believes that the high fentanyl prevalence and lack of normalization observed in study subjects could have confounded these results and made them difficult to interpret.

“We’re very pleased with the tolerability of BXCL501 observed across multiple doses, twice-a-day and for consecutive treatment days in this study, which we believe provides valuable insights as we explore additional indications and treatment settings that require multiple dosing regimens,” commented Reina Benabou, M.D., Ph.D., Senior Vice President & Chief Development Officer. “Treating opioid withdrawal is a significant national challenge, complicated by the more recent high rates of fentanyl addiction, which is significantly more potent and more prevalent than other opioids. We’re encouraged that the RELEASE study helped us to identify a dose range that was generally well tolerated and resulted in numerical improvements in retention in this patient population. We’ll continue to analyze these results in collaboration with our advisors regarding potential next steps for this important indication.”

“With more than 81,000 drug overdose deaths in the U.S. last year, there is an urgent need for improved strategies to help transition patients off opioids. Over the past five years, the epidemic has grown more challenging due to the widespread emergence of counterfeit fentanyl,” said Tom Kosten, M.D., Waggoner Professor in Psychiatry, Pharmacology, Neuroscience and Immunology at Baylor College of Medicine. “The results from the RELEASE study, which identified dosing regimens for BXCL501 that were well tolerated, showed that more patients receiving BXCL501 were able to complete treatment, suggesting that BXCL501 may have potential as a non-opioid based treatment option to address this unmet need.”

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