BioXcel Therapeutics Stock Tumbles: Company Releases Mixed Results From Lower Dose Igalmi Study In Bipolar/Schizophrenia Associated Agitation

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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