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Investing.com -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX) stock surged 27% on Monday after the company announced positive topline results from its Phase 2 RADIANT study evaluating vormatrigine in patients with focal onset seizures.
The clinical-stage biopharmaceutical company reported that dosing with vormatrigine over an eight-week period led to a 56.3% median reduction in seizure frequency. Approximately 22% of patients achieved complete elimination of seizures in the last 28 days of treatment, while over 54% of patients reached a 50% response rate within the first week of treatment.
Marcio Souza, president and chief executive officer of Praxis, described the results as "best-in-disease" and highlighted vormatrigine’s potential as a "fast-acting, highly efficacious and tolerable therapy" for focal epilepsy patients. The drug is being developed as a once-daily oral medication that requires no titration or food intake requirements.
"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 stated.
The company reported that vormatrigine was generally well tolerated and continues to demonstrate a favorable safety profile. Praxis is on track to complete its pivotal 12-week POWER1 study in the fourth quarter and plans to initiate the POWER2 study soon.
Dr. Jacqueline French, Professor at NYU Langone Health’s Comprehensive Epilepsy Center, noted that despite existing sodium channel therapies for focal onset seizures, "there remains substantial room for improvement within this class."
Additional data from the study will be presented at upcoming scientific conferences, including the 36th International Epilepsy Congress on August 31 in Lisbon, Portugal.
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