Praxis Precision Medicines Receives PRIME Designation from the EMA for elsunersen (PRAX-222) for Treatment of SCN2A Gain of Function Developmental Epilepsies
BOSTON, Nov. 16, 2023 (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 that the European Medical Agency (EMA) has awarded its Priority Medicines (PRIME) designation for elsunersen (PRAX-222) for the treatment of SCN2A Gain of Function (GoF) developmental and epileptic encephalopathy (DEE). The EMA’s PRIME designation provides enhanced development support for priority medicines that target an unmet need and was granted based on the Part 1 data from the EMBRAVE study that showed a reduction in seizures and improvement in seizure free days, as well as preclinical data.
“Elsunersen has the potential to significantly impact the lives of patients with SCN2A-DEE and their families,” said Marcio Souza, president and chief executive officer of Praxis. “We welcome the recognition by the EMA of not only the unmet need in the condition, but the breakthrough potential of elsunersen and look forward to working closely with patients and regulators globally to advance the program.”
The PRIME designation provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or a benefit to patients without treatment options. These medicines are considered priority medicines by the EMA, whose aim is to optimize development plans and accelerate evaluations so medicines that address significant unmet medical needs can reach patients faster.
About the EMBRAVE Study
About elsunersen (PRAX-222)
Investor Contact: Praxis Precision Medicines [email protected] 857-702-9452 Media Contact: Ian Stone Canale Communications [email protected] 619-849-5388
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