BioXcel Therapeutics Inc BTAI shares are tumbling after the company released topline results for TRANQUILITY II, a Phase 3 trial of BXCL501 for the acute treatment of Alzheimer's disease-related agitation.
The Phase 3 trial met its primary efficacy endpoint with the 60 mcg dose; a statistically significant and clinically meaningful 7.5 point reduction from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score was observed at 2 hours versus 5.4 with placebo (p=0.0112).
The 60 mcg dose also met the first key secondary endpoint of reducing agitation symptoms at 1 hour during the first episode of agitation (p=0.0185) but did not meet the other secondary endpoint of change from baseline in PEC score at 30 minutes.
Also, the primary endpoint was not met for the 40 mcg dose, with a 5.7 point reduction from baseline in the PEC score.
76% responded to the first 60 mcg dose and were determined to be "Very Much" or "Much Improved" compared to 50% with placebo.
Dosing with 60 mcg showed a reduction in PEC total score from pre-dose versus placebo at 1 hour (p=0.011) and 2 hours (p=0.0044) for all episodes of agitation.
BXCL501 was well tolerated, with a side effect profile substantially consistent with prior trials of BXCL501 and the current label for IGALMI (dexmedetomidine), indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.
The company plans to develop a path to potential supplemental submission for the acute treatment of agitation associated with Alzheimer's disease in H2 2023, subject to further discussions with the FDA.
Price Action: BTAI shares are down 58.70% at $7.30 on the last check Thursday.
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