Praxis Precision Medicines to Start PRAX-222 Study After FDA Clearance

 Praxis Precision Medicines Inc. said Wednesday it plans to start its PRAX-222 clinical study for the treatment of pediatric patients with early-seizure-onset SCN2A developmental and epileptic encephalopathy.

The biopharmaceutical company said the U.S. Food and Drug Administration has cleared the Investigational New Drug application for the initial dose cohort of PRAX-222.

Following collection of the safety and efficacy data from the first cohort of patients in the study, the data will be evaluated and submitted to the FDA to seek authorization for further dose escalation.

Praxis also said it intends to start a PRAX-562 Phase 2 study for the treatment of pediatric patients with SCN2A and SCN8A DEEs outside of the U.S. before the end of 2022, after the FDA placed a clinical hold on its second IND application for PRAX-562.

PRAX-562 has been dosed in over 130 healthy volunteers in completed and continuing studies, including 66 in the U.S. under an initial IND for adult rare headache conditions. Following the clearance of the initial IND last year, Praxis completed the chronic and juvenile toxicology programs and submitted a second IND to the FDA.

Praxis has begun discussions with the FDA to provide clarification about the pre-clinical and clinical data packages in relation to the clinical hold correspondence. Topline results for the PRAX-562 Phase 2 study for the treatment of pediatric patients with SCN2A and SCN8A DEEs are expected in 2023.

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