[Asia Economy Reporter Chunhee Lee] GNT Pharma announced on the 31st that its stroke treatment drug under development, 'Nellonemdaz,' has received approval from the Ministry of Food and Drug Safety for its Phase 3 clinical trial plan.
This Phase 3 approval is the first for a stroke drug developed domestically in Korea. It is the world's second Phase 3 clinical trial for a neuroprotective drug for stroke patients undergoing thrombectomy, following the Canadian drug development company Nono's 'Nerinetide (NA-1)'.
This Phase 3 clinical trial will verify the disability improvement effect and neuroprotective effect of Nellonemdaz in acute ischemic stroke patients who undergo thrombectomy within 12 hours of onset. The trial will be conducted on 496 patients diagnosed with moderate to severe ischemic stroke based on initial CT or MRI imaging at 23 university hospital stroke centers, including Seoul Asan Medical Center.
When a cerebral blood vessel is blocked by a stroke, the excitatory neurotransmitter 'glutamate' is excessively released in the brain, stimulating NMDA receptors and causing neuronal cell death. Additionally, reactive oxygen species generated upon reperfusion cause further neuronal cell death, leading to permanent disability or death. Previous research on neuroprotective drugs targeting either NMDA receptors or reactive oxygen species alone has failed due to side effects and lack of efficacy.
GNT Pharma's Nellonemdaz is the world's first 'multi-target' neuroprotective drug that inhibits NMDA receptor activity while scavenging reactive oxygen species to prevent neuronal cell death. The company evaluates that the safety and disability improvement effects of Nellonemdaz have been confirmed through Phase 1 clinical trials involving 165 healthy volunteers in the US and China, and Phase 2 clinical trials involving 447 stroke patients in Korea and China. Notably, in the domestic Phase 2 trial involving 209 stroke patients who underwent thrombectomy within 8 hours, Nellonemdaz showed significantly improved disability outcomes compared to the placebo group across the three major stroke efficacy evaluation scales. Furthermore, serious side effects such as psychiatric symptoms, which have been concerns with NMDA receptor inhibitors, were not observed.
Denis Choi, Professor of Neurology at Stony Brook University School of Medicine and advisor for the Nellonemdaz Phase 3 trial, said, "Stroke occurs through multiple pathways, and previous drug development efforts targeting only one pathway have failed. The Phase 2 results of the multi-target drug Nellonemdaz are very optimistic, so the Phase 3 results are highly anticipated."
Byungjoo Kwak, CEO of GNT Pharma (also an adjunct professor at Yonsei University's Department of Life Sciences), stated, "In 2016, we conducted the world's first Phase 2 clinical trial on stroke patients who underwent thrombectomy, confirming the efficacy and safety of Nellonemdaz. Our goal is to successfully complete the approved Phase 3 trial and launch the stroke treatment drug by 2025."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
