Praxis Precision announces results from two Phase 3 studies of ulixacaltamide

Praxis Precision (PRAX) Medicines announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor, ET. Patients treated with ulixacaltamide in the parallel-group study showed a mean improvement from baseline in the Modified Activities of Daily Living 11 at Week 8, the pre-specified primary endpoint, of 4.3 points. All key secondary endpoints in Study 1 – rate of disease improvement over 12 weeks, PGI-C and CGI-S – were also statistically significant. Study 2 met its pre-specified primary endpoint, with patients showing superior maintenance of effect while on ulixacaltamide versus placebo during the randomized-withdrawal phase. The first key secondary endpoint in Study 2 – rate of disease improvement during the randomized-withdrawal phase – also demonstrated superior effect in ulixacaltamide treated patients versus placebo.