BioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study

BioXcel Therapeutics Inc BTAI has announced topline results from its Phase 1b/2 proof-of-concept RELEASE study evaluating BXCL501 for the treatment of opioid withdrawal symptoms.
BXCL501 is the Company's proprietary, orally dissolving thin film formulation of dexmedetomidine.
The study met its primary safety endpoint across multiple doses (30 mcg to 240 mcg) given twice-daily over seven days. BXCL501 was well tolerated.
The highest BXCL501 (240 mcg) dose was associated with cardiovascular and nervous system treatment-emergent adverse events, versus none in the placebo group.
Concerning 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% retention rates 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.
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.
Price Action: BTAI shares are down 7.7% at $39.86 in the premarket session on the last check Thursday.

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