Neurona Therapeutics announces clinical trial for drug-resistant focal epilepsy treatment
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Neurona Therapeutics has announced that a phase 1/2 clinical trial for NRTX-1001, a regenerative neural cell therapy for treatment of drug-resistant focal epilepsy in adults, is now underway.
According to a company press release, NRTX-1001 is delivered as a one-time dose and is designed to provide long-term secretion of gamma-aminobutyric acid, a key inhibitory neurotransmitter, to repair hyper-excitable neural networks associated with mesial temporal lobe epilepsy (MTLE), the most common form of focal epilepsy in adults.
“Administration of NRTX-1001 to the first patient in our clinical trial for MTLE represents a huge milestone for Neurona and the neurology field,” Cory R. Nicholas, PhD, Neurona’s president and CEO, stated in the release. “We are very excited to take this next step, bringing a first-in-class, novel regenerative treatment to people living with chronic focal seizures.”
According to the release, the aim of Neurona’s multicenter clinical trial is to determine safety and efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. The first stage of the trial is an open-label dose-escalation study, which will include up to 10 people with MTLE. Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, neural cell viability and effects on their epilepsy disease symptoms. Trial enrollment is underway at centers throughout the United States.
“Neurona’s regenerative cell therapy approach has the potential to provide a single-administration, non-destructive alternative for the treatment of drug-resistant focal epilepsy,” Harish Babu, MD, PhD, assistant professor of neurosurgery at SUNY Upstate Medical University and the surgeon who administered the first dose of NRTX-1001, said in the release. “Currently, people with mesial temporal lobe epilepsy who are not responsive to anti-seizure medications have few options, such as an invasive surgery that removes or destroys the affected brain tissue.”