BioXcel Therapeutics Inc (NASDAQ: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.
Price Action: BTAI shares are up 2.8% at $28.00 on the last check Tuesday
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