Praxis Precision Medicines' Ulixacaltamide HCL Study 1 For Essential Tremor, Met Primary Endpoint, All Key Secondary Endpoints In Study 1 Were Also Statistically Significant

Author: Benzinga Newsdesk | October 16, 2025 06:13am

• Patients treated with ulixacaltamide in the parallel-group study (Study 1) 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 (p<0.0001) 
• All key secondary endpoints in Study 1 - rate of disease improvement over 12 weeks, PGI-C and CGI-S - were also statistically significant (p<0.001)
• 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 (p=0.0369)
• 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 (p=0.0042)
• Ulixacaltamide was generally well tolerated with a safety profile consistent with previous trials and no drug-related serious adverse events
• Praxis has submitted a pre-NDA meeting request to the FDA

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