BioXcel Therapeutics announces FDA acceptance of IND for BXCL501

BioXcel Therapeutics announced that the FDA has accepted its Investigational New Drug, or IND, application for lead neuroscience candidate, BXCL501. BTI plans to evaluate BXCL501, a proprietary sublingual thin-film formulation of dexmedetomidine in a first-in-human pharmacokinetic and safety study in healthy volunteers. BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology. The IND-opening Phase 1 study is a placebo-controlled, single-dose, dose-escalation study of BXCL501 that is expected to enroll up to 60 healthy adult volunteers across various dosing groups. The primary endpoints are pharmacokinetics and safety, with secondary endpoints including assessment of pharmacodynamics, or PD, and the relationship between BXCL501 concentrations and PD endpoints. The company expects to report top-line data from the study in the first half of 2019 that will provide a path for BTI to launch the anticipated registration studies.
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