Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy
Shots:
- The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data
- NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE
- The P-I/II unilateral MTLE trial results presented at AAN’25 showed a 92% median seizure reduction at 7–12mos., 4/5 pts (Cohort 1: low dose) having >75% seizure reduction at 12mos., durable seizure control in all responders at 18–24mos., & improved QoL in all 5 pts with no cognitive decline. Updated data to be presented at AES’25
Ref: Neurona Therapeutics| Image: Neurona Therapeutics| Press Release
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