- BioXcel Therapeutics Inc BTAI announced results for BXCL501, an orally dissolving film of dexmedetomidine, from Part 1 of Phase 3 SERENITY III trial designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use.
- Part 1 assessed the efficacy and safety of a 60mcg dose, half of the already-approved 120mcg dose (Igalmi).
- Also Read: BioXcel Therapeutics Reports Encouraging Phase 1b Results For Innovative Depression Treatment.
- The results are expected to enable the initiation of Part 2 for at-home use. BXCL501 would represent the first-ever FDA-approved therapy for at-home use in this indication if approved.
- The company plans to proceed with SERENITY III Part 2 using an adaptive trial design with 60mcg or greater dose, such as 80mcg.
- Clinically meaningful efficacy results were observed with half (60mcg) of the lowest approved dose of Igalmi.
- In addition, a greater than 50% PEC response rate was achieved, with a responder rate dose-proportionally consistent with those observed in SERENITY I and II trials.
- Although the primary efficacy endpoint was not statistically significant at 2 hours (p=0.077), BXCL501 separated from placebo at 4 hours (p=0.049).
- 52% were PEC responders by 2 hours post-dose (p = 0.019 versus placebo). The proportion responding was greater than with placebo as early as 1 hour (p = 0.035) and remained so through 4 hours.
- The proportion responding by CGI-I assessment (achieving a score of 1 or 2, 'Very much improved' or 'Much improved', respectively) was greater than with placebo at 2 hours post-dose (p = 0.039).
- Price Action: BTAI shares are down 27.5% at $18.80 on the last check Thursday.
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