GNT Pharma's Stroke Drug 'Nellonemdaz' Clinical Phase 3 Gains Support from Global Experts

Genetopharma announced on the 24th that world-renowned experts in stroke diagnosis and clinical fields will participate as clinical researchers in the multinational Phase 3 clinical trial of Nellenemdaz, which aims to develop a stroke treatment and is planning to submit an Investigational New Drug (IND) application within this year.

Raul Noguera, Director of the Stroke Center at the University of Pittsburgh School of Medicine, USA (left), and Byungjoo Kwak, CEO of GNT Pharma
[Photo by GNT Pharma]

Currently, Genetopharma is drafting the protocol for a multinational Phase 3 stroke clinical trial to confirm the efficacy of Nellenemdaz observed in domestic Phase 2 and Phase 3 stroke clinical trials. The company plans to submit the IND to the Korean Ministry of Food and Drug Safety within this year. This clinical trial will initially be conducted in Korea and the United States, with additional clinical trial institutions that comply with Good Clinical Practice (GCP) standards to be selected in countries such as Europe, China, and Australia.

The clinical trial will include Raul Nogueira, Director of the Stroke Center at the University of Pittsburgh School of Medicine, and David Liebeskind, Director of the Stroke Center at the University of California, Los Angeles (UCLA) School of Medicine, as clinical researchers. Professor Nogueira, a former president of the Society of NeuroInterventional Surgery, is recognized as a global authority in stroke, having led groundbreaking clinical trials in stroke thrombectomy procedures and published 450 papers in prestigious journals such as the New England Journal of Medicine (NEJM), The Lancet, and the Journal of the American Medical Association (JAMA).

Professor Nogueira stated, “The efficacy of Nellenemdaz observed in Phase 3 stroke clinical trials conducted in Korea and China, where patients received rapid drug and reperfusion treatment after arriving at the emergency room, is encouraging. Conducting an adaptive clinical trial by selecting patients with severe stroke in this trial will be even more effective.” Adaptive clinical trials are a method of clinical research that selectively enrolls patients who show confirmed drug efficacy based on interim analysis results and protocol criteria. Since stroke patients have high variability, selecting responsive patients through adaptive trials is ethical and more efficient, reducing both the clinical trial duration and the number of patients required.

Professor Liebeskind, a world-renowned expert in cerebrovascular imaging diagnosis who has published 257 papers on stroke patient treatment and cerebrovascular imaging analysis in NEJM, The Lancet, and JAMA, explained, “It is entirely feasible for stroke patients arriving at the emergency room to receive rapid drug administration and thrombectomy procedures. In this clinical trial, it is important to select target patients through precise cerebrovascular analysis.”

Previous domestic Phase 2 and Phase 3 acute stroke clinical trials also showed that the efficacy of Nellenemdaz was related to the timing of drug administration and thrombectomy procedures. Among 47 patients who received the drug within one hour of arriving at the emergency room, the Nellenemdaz group (24 patients) showed a 4.93-fold statistically significant improvement in disability compared to the placebo group (23 patients). Significant efficacy of Nellenemdaz was also confirmed in 140 patients who received the drug within 80 minutes of emergency room arrival.

Jinsu Lee, Chief Professor of Neurology at Ajou University Hospital, who analyzed the clinical trials of Nellenemdaz, said, “By minimizing patient variability through more precise brain imaging, selecting patients with severe stroke, and promptly administering the drug and performing thrombectomy procedures, the disability improvement effect of Nellenemdaz is expected to be even greater.”

Byungjoo Kwak, CEO of Genetopharma, said, “While preparing the clinical trials with world-class stroke clinical experts, we confirmed the importance of translational clinical research based on scientific evidence. Once the disability improvement efficacy of Nellenemdaz is confirmed, we will apply for marketing authorization in countries including Korea and the United States as the first neuroprotective drug for stroke patients worldwide.”

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