GNT Pharma's 'Nellonemdaz' Launches Multinational Phase 3 Stroke Clinical Trial

Genetipharm announced on the 9th that it has submitted the clinical trial protocol (IND) for the Phase 3 clinical trial to confirm the efficacy of 'Nellonemdaz,' a stroke treatment drug under development, to the Ministry of Food and Drug Safety.

'Nellonemdaz', a stroke treatment drug under development by GenT Pharma. Provided by GenT Pharma

Genetipharm has completed the multinational Phase 3 clinical trial (RENEW) protocol to confirm the efficacy of Nellonemdaz, which was verified in domestic Phase 2 and Phase 3 stroke clinical trials, and plans to conduct clinical trials in Korea, the United States, Australia, and other countries.

The multinational Phase 3 clinical trial will be conducted on 788 patients with severe stroke who undergo thrombectomy within 12 hours of onset. Patients with a history of diabetes are excluded, and it is recommended that the initial drug administration after arrival at the emergency room be within 60 minutes, and thrombectomy be performed within 90 minutes. An interim analysis by an independent data monitoring committee (IDMC) will be conducted when 50% of the total trial participants are enrolled. If the interim analysis shows a statistically significant increase in the proportion of patients in the Nellonemdaz group who achieve disability improvement sufficient for independent living at 12 weeks after drug administration compared to the placebo group, the drug's efficacy will be declared verified, and the study will be terminated early.

The principal investigator of the multinational Phase 3 clinical trial is Professor Jinsoo Lee, Head of the Department of Neurology at Ajou University Hospital. World-renowned experts such as Professor Raul Noguera, Director of the Stroke Center at the University of Pittsburgh Medical Center, Professor David Liebeskind, Director of the Stroke Center at UCLA Medical Center, and Professor Henry Ma, Director of the Stroke Center at Monash University Hospital in Australia, will participate as research leaders. More than ten university hospitals in Korea will participate in the domestic clinical trial. Additional trials will be conducted in Europe, China, and other countries once clinical trial institutions that comply with clinical trial management standards are selected.

Nellonemdaz is the world's first multi-target neuroprotective drug for stroke discovered by Genetipharm with support from the Ministry of Science and ICT. It has been confirmed to have superior effects in inhibiting brain cell death caused by stroke compared to comparator drugs.

An integrated analysis of Phase 2 and Phase 3 clinical trials conducted on ischemic stroke patients who underwent thrombectomy showed that in severe patients without a history of diabetes, the proportion of patients able to live independently at 12 weeks was significantly higher in the Nellonemdaz group compared to the placebo group. Additionally, patients who received Nellonemdaz within 60 minutes of arrival at the emergency room showed significantly improved disability at 12 weeks compared to the placebo group. The Phase 2 clinical trial results were published in the international journal Stroke in 2022, and the Phase 3 clinical trial results were recently approved for publication in JAMA Network Open, a journal of the American Medical Association (AMA).

Byungjoo Kwak, CEO of Genetipharm (also an adjunct professor in the Department of Life Sciences at Yonsei University), stated, "If medically significant efficacy is confirmed in the multinational Phase 3 clinical trial, we will apply for national marketing authorization as the first global new drug for stroke."

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