- Practice Precision Medicines Inc PRACTICE plans to start the PRAX-222 EMBRAVE study in pediatric patients with SCN2A developmental and early-onset epileptic encephalopathy (DEE).
- Upon collection of safety and efficacy data from the first patient cohort of the EMBRAVE study, the data will be analyzed and submitted to the FDA for approval of further dose escalation.
- Praxis also announced that it intends to initiate the Phase 2 PRAX-562 study in pediatric patients with SCN2A and SCN8A DEEs outside the US before the end of 2022 The FDA has ordered a clinical lockdown on his second IND filing for PRAX-562.
- Related: Praxis Precision releases disappointing data from depression study.
- PRAX-562 has been administered to over 130 healthy volunteers in completed and ongoing studies.
- Topline results from the Phase 2 PRAX-562 study in pediatric patients with SCN2A and SCN8A DEEs are expected in 2023.
- The PRAX-222 program runs in cooperation with Ionis Pharmaceutics Inc IONS and RogCon Inc.
- Price promotion: PRAX shares are down 4.83% to $3.04 on the latest check Wednesday.
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