BioXcel Therapeutics (NASDAQ:BTAI) soars 34% premarket on the heels of its announcement that BXCL501, its proprietary sublingual thin film formulation of dexmedetomidine, met the primary and secondary endpoints in two late-stage studies in schizophrenia and bipolar disorder.
In patients with schizophrenia (SERENITY I) and a second study of bipolar disorder (SERENITY II), highly statistically significant and clinically meaningful reductions in the Positive and Negative Syndrome Scale, Excitatory Component (PEC) score at two hours, the primary endpoint, were reported for both high and low dose cohorts of BXCL501 compared to placebo (p<0.0001).
In SERENITY I trial, 67% and 87% of patients achieved response rate (>40% reduction in PEC scores) at 120 mcg and 180 mcg dose level, respectively.
69% and 85% of patients showed response at 120 mcg and 180 mcg doses, respectively in SERENITY II trial.
Both studies also met the key secondary endpoint, demonstrating improvement in PEC scores beginning as early as 20 minutes in patients with bipolar disorder, at both dose levels (120 and 180 mcg), and as early as 20 minutes in patients with schizophrenia for the 180 mcg dose level.
Exploratory efficacy endpoints confirmed the primary endpoint, with duration of response lasting at least four hours after treatment.
No new safety signals were observed.
The Company is also exploring the potential of BXCL501 in other hyperarousable disease states, such as post-traumatic stress disorder, traumatic brain injury, alcohol withdrawal and as a treatment for phobias.
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