[Korean News] GNT Pharma's positive Phase 3 clinical trial results on 'Nelonemdaz' for stroke

South Korean GNT Pharma Co. Ltd announced on the 13th of this month, that administering their stroke treatment drug 'Nelonemdaz' to patients within one hour of arrival at the emergency room showed nearly a five-fold improvement in disability compared to a placebo treatment.

The chief investigator of the Phase 3 trial at Seoul Asan Hospital's Neurology Department, presented the key findings at ISC 2024 held at the Phoenix Convention Center in Arizona, USA. It has been reported that the Phase 3 trial of Nelonemdaz targeted severe stroke patients receiving intravenous thrombolysis within 12 hours of onset. The 496 patients in this trial received medication within 7 hours of onset upon arrival at the emergency room and underwent thrombolysis simultaneously, analyzing disability improvement and safety 12 weeks later. The efficacy of Nelonemdaz was found to be related to the time of medication administration and thrombolysis. Particularly, among 47 patients who promptly received medication within one hour of arrival at the emergency room, the Nelonemdaz group (24 patients) showed a 4.93-fold improvement in disability treatment effects compared to the placebo group (23 patients), which was medically significant and statistically proven (p=0.004).

GNT Pharma plans to conclude clinical trials by the end of this year and commercialize Nelonemdaz in South Korea. GNT Pharma is also preparing Phase 3 clinical trials for indications related to cardiac arrest for Nelonemdaz.

This news is particularly exciting as global pharmaceutical companies such as Merck and AstraZeneca have been reporting difficulties in the development of stroke medication; therefore more attention will now be drawn to the possibilities of commercializing stroke medications domestically.