Shares of Praxis Precision Medicines, Inc. (NASDAQ:PRAX) soared 27% on Monday after the company released encouraging top-line results from its Phase 2 RADIANT trial, which evaluated vormatrigine in individuals with focal onset seizures.
According to the clinical-stage biotech firm, patients treated with vormatrigine over an eight-week period experienced a 56.3% median reduction in seizure frequency. Notably, about 22% of participants saw a complete elimination of seizures during the final 28 days of treatment, and more than 54% reached a 50% response rate within just the first week.
Praxis CEO Marcio Souza praised the findings, calling them “best-in-disease” and emphasizing the drug’s promise as a “fast-acting, highly efficacious and tolerable therapy” for people with focal epilepsy. The investigational therapy is being developed as a once-daily oral pill that doesn’t require titration or specific food timing.
“These findings build on our earlier clinical data showing a differentiated profile for vormatrigine as a fast-acting, no-titration, once-daily oral drug with no requirement to be taken with food, and a favorable DDI profile, all of which are unseen in ASMs currently in the market or in development,” Souza added.
The company also reported that vormatrigine continues to show a positive safety and tolerability profile, with adverse events being manageable. Praxis expects to wrap up its pivotal 12-week POWER1 trial later this year and is preparing to launch the POWER2 trial shortly thereafter.
Commenting on the treatment landscape, Dr. Jacqueline French, professor at NYU Langone Health’s Comprehensive Epilepsy Center, noted that “there remains substantial room for improvement within this class”, even with existing sodium channel therapies for focal onset seizures.
Praxis plans to share more data from the study at upcoming medical events, including the 36th International Epilepsy Congress on August 31 in Lisbon, Portugal.
Praxis Precision Medicines stock price
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