Praxis Precision Medicines Touts Encouraging Data For Mid-Stage Epilepsy Drug

On Tuesday, Praxis Precision Medicines Inc. PRAX released topline results for its EMBOLD Phase 2 proof-of-concept study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathy (DEE) patients.

DEEs are characterized by seizures, encephalopathy (disturbance in brain function, and intellectual disability.

Patients on relutrigine observed a placebo-adjusted reduction of 46% in countable motor seizures.

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Change in Global Impression of Improvement, assessed by the caregiver and clinician at week 16 for patients on relutrigine, showed an improvement (caregiver, clinician) in disruptive behavior (29%, 23%), communication (43%, 31%), seizure severity and intensity (71%, 62%) and alertness (57%, 69%).

Eight patients have completed at least one 28-day period in the long-term extension of EMBOLD with a median reduction in motor seizures of 75%. Five patients achieved a 28-day seizure-free status while receiving relutrigine, compared to none on placebo.

Relutrigine was generally safe and well tolerated by patients during the EMBOLD study.

Seven patients increased the daily dose from 0.5 to 1 mg/kg/day during the double-blind period of the study.

No patient required a dose reduction. The most common adverse events (AEs) in patients receiving relutrigine were infections, vomiting, pyrexia, somnolence, and constipation.

No patients discontinued due to an AE.

In March, Praxis Precision provided an update on its Phase 2a proof of concept study evaluating PRAX-628 in epilepsy patients with photo paroxysmal response, also known as photosensitivity. 

Price Action: PRAX stock is down 2.90% at $51.61 at the last check on Tuesday.

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