- Praxis Precision Medicines Inc PRAX plans to start the PRAX-222 EMBRAVE study for pediatric patients with early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE).
- After collecting the safety and efficacy data from the first cohort of patients in the EMBRAVE study, the data will be evaluated and submitted to the FDA to seek authorization for further dose escalation.
- Praxis also announced that it intends to start the PRAX-562 Phase 2 study in 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.
- Related: Praxis Precision Posts Disappointing Data From Depression Study.
- PRAX-562 has been dosed in over 130 healthy volunteers in completed and ongoing studies.
- Topline PRAX-562 Phase 2 study results for pediatric patients with SCN2A and SCN8A DEEs are expected in 2023.
- The PRAX-222 program is ongoing under a collaboration with Ionis Pharmaceutics Inc IONS and RogCon Inc.
- Price Action: PRAX shares are down 4.83% at $3.04 on the last check Wednesday.
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