BioXcel Therapeutics Reports Encouraging Phase 1b Results For Innovative Depression Treatment

BioXcel Therapeutics Inc BTAI announced topline data from its Phase 1b multiple ascending dose (MAD) trial of BXCL501 (dexmedetomidine) sublingual film, for agitation associated with neuropsychiatric disorders and as a potential adjunctive treatment in Major Depressive Disorder (MDD).

The trial evaluated the safety and tolerability of repeat dosing of BXCL501 in healthy volunteers as a single agent and in combination with the antidepressant duloxetine.
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The trial successfully met the primary endpoints.
BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically. The maximum tolerated dose was not reached. All adverse events were reported as mild or moderate.
The profile of BXCL501 exhibited consistency between doses evaluated, proportional increases with dose, and no accumulation with once- or twice-daily dosing, consistent with the half-life of BXCL501.
The pharmacokinetics of BXCL501 were similar with or without duloxetine coadministration.
BioXcel Therapeutics plans to present Phase 1b MAD study results at an upcoming medical conference.
The company is developing a Phase 2 human POC trial design to investigate BXCL501 as an adjunctive treatment and its potential accelerant effect in combination with first-line SSRIs and SNRIs.