eClinical Technology and Industy News

Neurona Therapeutics Presents New Clinical Data from First Cohort in Ongoing Phase I/II Open-Label Trial of NRTX-1001 Cell Therapy for Drug-resistant Mesial Temporal Lobe Epilepsy (MTLE)

NRTX-1001 investigational treatment has been well tolerated in all initial subjects

Positive decision from data safety monitoring board (DSMB) on review of first cohort safety data greenlights dosing of five additional subjects in the second, highest dose, cohort

First two subjects continue to report a >95% reduction in overall average monthly seizure counts one year after treatment

Early clinical data will be presented at the Annual Meeting of the American Epilepsy Society

Excerpt from the Press Release:

SAN FRANCISCO, Dec. 01, 2023 (GLOBE NEWSWIRE) — Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapy candidates for the treatment of neurological disorders, announced presentation of positive preliminary clinical data from the first cohort of five subjects in its ongoing open-label, single-arm Phase I/II clinical trial of NRTX-1001, an investigational allogeneic cell therapy candidate that is being developed for treatment of drug-resistant MTLE. The data will be presented at the Annual Meeting of the American Epilepsy Society, which is being held December 1-5, 2023 in Orlando, Florida.

Separately, the Data Safety Monitoring Board (DSMB) overseeing the Phase I/II trial cleared continuing enrollment for another five patients who will receive a one-time administration of the higher dose level of NRTX-1001.

“The DSMB’s decision to allow the enrollment of five more subjects in our ongoing open-label Phase I/II clinical trial is a testament to NRTX-1001 being well-tolerated in the first cohort,” said Cory R. Nicholas, Ph.D., Neurona’s chief executive officer. “The early data from the first cohort in the trial have been very encouraging, with substantial, durable seizure reduction in the first subjects with drug-resistant MTLE. We look forward to advancing the development of NRTX-1001 cell therapy with our top-dose cohort of five subjects now enrolling into early 2024.”

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