Thinly traded micro cap BioXcel Therapeutics (NASDAQ:BTAI) is up 8% premarket on average volume in response to positive data from a Phase 1b clinical trial evaluating multiple doses of Fast Track-tagged BXCL501 for the acute treatment of agitation in 135 schizophrenia patients.
The three doses tested, 80 mcg, 120 mcg and 180 mcg, showed rapid calming without excessive sedation at hour two and earlier in a dose-dependent manner. The treatment effects for all three were statistically significant compared to placebo.
On the safety front, the most common treatment-related adverse events were drowsiness and dry mouth.
A pivotal Phase 3 study is next up pending a meeting with the FDA to clarify the design and protocol.
BXCL501 is a sublingual thin film formulation of the sedative dexmedetomidine, the active ingredient in Pfizer’s Precedex.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.