Praxis Precision Medicines to Advance PRAX-562 Phase 2 Study in Pediatric Patients with Developmental and Epileptic Encephalopathies

Excerpt from the Press Release:

BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced plans to initiate the PRAX-562 Phase 2 EMBOLD study for the treatment of pediatric patients with developmental and epileptic encephalopathies (DEEs), following U.S. Food and Drug Administration (FDA) authorization to proceed with the study as proposed by Praxis, up to the planned maximum dose of 1.0 mg/kg/day. The EMBOLD Study is expected to initiate in the U.S in the first quarter of 2023, with two distinct cohorts in early-onset SCN2A-DEE and SCN8A-DEE patients. Topline results for both cohorts are expected in the second half of 2023.

“We designed PRAX-562 as a significantly differentiated sodium channel inhibitor specifically for the treatment of DEEs, with a goal of bringing the first precision treatment option to patients living with these devastating forms of epilepsy,” said Steven Petrou, co-founder and chief scientific officer of Praxis. “Every day matters for these patients and their caregivers, and we look forward to initiating the EMBOLD study to evaluate the promise of PRAX-562 for the treatment of SCN2A, SCN8A and other DEEs.”

The EMBOLD Study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the safety, tolerability, efficacy (motor seizure frequency) and pharmacokinetics (PK) of PRAX-562 in pediatric participants aged 2 to 18 years with DEEs, followed by an open-label extension.

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