Boston, USA-based biotech Praxis Precision Medicines (Nasdaq: PRAX) has provided an update on the interim analysis for Study 1 of the Essential3 program of ulixacaltamide in essential tremor (ET), sending the firm’s shares tumbling more than 40% to $38.60 on Friday.
The company noted that the Independent Data Monitoring Committee (IDMC) overseeing the interim analysis of Study 1 of the Essential3 program has recommended that the study be stopped for futility, due to the results being unlikely to meet the primary efficacy endpoint under the parameters set by the statistical model. The committee also indicated that some underlying assumptions of the statistical model might have influenced this outcome and encouraged Praxis to explore alternative analysis methods.
Ulixacaltamide is the company's most advanced program, and Praxis had anticipated a regulatory filing this year. The drug showed "meaningful improvement" in TETRAS Activities of Daily Living (ADL) measures among patients receiving propranolol.
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