The number of patients registered for phase 3 clinical trials of GNT Pharma’s stroke treatment, Nelonemdaz, has exceeded 100, raising expectations for completing all related trials in 2023 as scheduled, the company said Tuesday.

Phase 3 clinical trials for GNT Pharma’s new stroke treatment, Nelonemdaz, will likely proceed smoothly, given the active registration of patients as subjects.
Phase 3 clinical trials for GNT Pharma’s new stroke treatment, Nelonemdaz, will likely proceed smoothly, given the active registration of patients as subjects.

Nelonemdaz is the first drug candidate worldwide that received approval for phase 3 stroke clinical trials from the Ministry of Food and Drug Safety.

The trial will test the effectiveness of improving disability, brain cell protection, and safety after administration on 496 patients who undergo thrombectomy within 12 hours. Stroke centers at 23 university hospitals in Korea will participate in the trial and Professor Kwon Soon-eok of the Department of Neurology at Asan Medical Center will lead the trials.

GNT Pharma plans to apply to the U.S. Food and Drug Administration for an additional phase 3 clinical trial in the investigational new drug (IND) process of Nelonemdaz’s stroke trials this year. In addition, the phase 3 clinical trial in China is also progressing smoothly at 39 university hospitals.

Amid the recent surge in confirmed Covid-19 patients, stroke patients are also on the rise.

"Patients who recover from the novel coronavirus infection found their stroke rate increase by 52 percent within a year regardless of age and gender." Professor Ali of the University of Washington said in the journal Nature Medicine in March. Accordingly, the need for an effective stroke treatment is vital.

Nelonemdaz, a new substance that inhibits NMDA receptor activity and removes active oxygen simultaneously, is the world's first “multiple target” brain cell protection drugs to prevent brain cell death after a stroke, according to GNT Pharma. In addition, phase 2 clinical trials showed that the drug had a more pronounced effect on improving disability in patients in a more critical state.

Other pharmaceutical companies have only succeeded in developing a single target brain cell protection drug, which failed in clinical trials due to side effects and lack of medicinal effects, the company said.

"Nelonemdaz has proven effective and safe in 447 stroke patients." GNT Pharma CEO Kwak Byung-joo said. "As the registration of Nelonemdaz clinical phase 3 patients is accelerating, we expect to commercialize the stroke treatment in three years depending on the results."

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