By Colin Kellaher
Praxis Precision Medicines has hit a bump in its Phase 3 program for its ulixacaltamide drug candidate in essential tremor.
Praxis on Friday said the independent data monitoring committee overseeing an interim analysis of Study 1 of the "Essential3" program has recommended that the study be stopped for futility because it is unlikely to meet the primary efficacy endpoint under the parameters set by the statistical model.
Praxis said the panel indicated that some underlying assumptions of the statistical model might have influenced the outcome and encouraged the Boston clinical-stage biopharmaceutical company to explore alternative analysis methods.
However, Praxis said that given the advanced state of enrollment for Study 1 and Study 2 in the Essential3 program, it will continue both studies to completion, with topline results expected in the third quarter.
The company said it will make a decision about whether the data supports seeking Food and Drug Administration approval of the drug after it analyzes the final results for the two studies.
Praxis said it is disappointed with and surprised by the outcome of the interim analysis for Study 1, adding that it plans to explore different analysis methods for the final dataset.
Trading in shares of Praxis, which closed Thursday at $65.03, was halted premarket on Friday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 28, 2025 08:30 ET (13:30 GMT)
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