PRAX - Praxis crashes 42% after mid-stage data for movement disorder candidate

Despite its plans to advance ulixacaltamide, a candidate for movement disorder essential tremor (ET), towards Phase 3 development, Praxis Precision Medicines ( NASDAQ: PRAX ) lost ~42% pre-market Friday after announcing mixed results from a Phase 2 trial.

Citing topline data from its Essential1 Phase 2b study, Praxis ( PRAX ) said that the 132-patient trial indicated benefit from ulixacaltamide (PRAX-944) in ET compared to placebo in terms of the primary endpoint but without statistical significance (p=0.126).

The study tested the impact of daily daytime treatment of ulixacaltamide at 60 or 100-mg doses. Its primary endpoint was the change in the modified Activities of Daily Living (mADL1) score after 56 days from the baseline.

However, the company said there were statistically significant improvements for certain secondary endpoints, including the TETRAS-ADL subscale (p=0.026). The study drug was well tolerated indicating a safety profile consistent with prior findings.

“It’s clear to us based on these results and prior clinical experience, that ADLs are the preferred endpoint for a registrational study for essential tremor,” Chief Executive of Praxis ( PRAX ) Marcio Souza noted.

The company intends to meet the FDA at an end of Phase 2 meeting and plans to begin a Phase 3 study in H2 2023 for ulixacaltamide in ET.

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