BioXcel Therapeutics, Inc. (NASDAQ:BTAI) shares regressed Friday, a day after the company's acute agitation treatment, BSCL501, received FDA Fast Track Designation.
The New Haven-based BioXcel said FDA's Fast Track program is designed to provide certain benefits for new drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
The designation provides the opportunity for more frequent meetings with the FDA over the course of development and allows for the potential of rolling submission of individual sections of a New Drug Application for review. If supported by clinical data, this designation allows for the potential of priority review.
CEO Vimal Mehta said, "Fast track designation for BXCL501 highlights FDA’s recognition of our investigational therapy as a possible treatment for acute agitation associated with schizophrenia, bipolar disorder and dementia.
"This regulatory milestone will help facilitate clinical development and expedite regulatory review of BXCL501, bringing us closer to potentially delivering an optimal therapeutic solution effective for both patients and caregivers."
BTI is currently conducting a Phase 1 study placebo-controlled, single dose, dose-escalation study of BXCL501. The study 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 (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.
BTIA shares lost 28 cents, or 6.4%, Friday to $4.08
