Neurona Therapeutics has reported promising results from its ongoing Phase 1/2 trials evaluating rezanecel (NRTX-1001), an allogeneic interneuron cell therapy for drug-resistant mesial temporal lobe epilepsy (MTLE). In participants with unilateral MTLE and mesial temporal sclerosis (MTS), a low dose of rezanecel achieved an 89% median reduction in disabling seizures over a 7-12 month period, while those without MTS experienced a 100% median reduction during a 4-6 month interim evaluation. For bilateral MTLE, a 64% median reduction was observed, highlighting the therapy’s potential across different patient cohorts.

The significance of these findings lies in their implications for patients who are often underserved by current treatment options, such as lobectomy or brain stimulation. The durability of seizure reduction beyond the one-year mark, coupled with a favorable safety profile—showing no serious adverse events related to the therapy—suggests that rezanecel could provide a long-lasting solution for those with drug-refractory epilepsy. Cognitive assessments indicated no substantial declines in performance, further supporting the therapy’s safety.

The upcoming Phase 3 EPIC trial, set to begin in the second half of 2026, will further evaluate the efficacy and safety of rezanecel in a larger, randomized cohort. This pivotal trial not only aims to confirm the promising preliminary data but also to establish rezanecel as a viable therapeutic option, potentially shifting the landscape of treatment for drug-resistant MTLE. The acceptance of rezanecel as the non-proprietary name by the WHO/INN underscores its readiness for broader clinical application and regulatory recognition.

Source: globenewswire.com