[팜뉴스=이권구 기자] GNT Pharma (CEO Kwak Byung-joo) announced on the 20th that the Korean phase 2 clinical study paper of ‘Nellonemdaz’, a stroke treatment, was published in the September issue of ‘Stroke’, the international academic journal of the American Heart Association .
The research paper published in the journal includes the results of analyzing the efficacy and safety of Nelonemdaz in 208 stroke patients who underwent thrombectomy within 8 hours of its initiation.
According to the research paper, the disability improvement effect of Nelonemdaz was improved compared to placebo (placebo) in the three major stroke drug effectiveness evaluations (disability evaluation, daily living evaluation, and neurological evaluation).
A Phase 2 clinical trial of Nelonemdaz was conducted in patients aged 19 years or older with large vessel occlusion in the anterior circulation who underwent drug surgery and thrombus removal within 8 hours of an acute ischemic stroke. The patient received a placebo, a low dose (total Nellonemdaz 2,750 mg), and a high dose (total Nellonemdaz 5,250 mg) 10 times every 12 hours for 5 days, and the efficacy and safety of drugs were investigated over 12 weeks.
Among 183 patients who received one or more doses of the drug and completed the mRS analysis, a stroke disability rating scale, after 12 weeks, the proportion of mRS scores from 0 to 2 (able to function independently) after 12 weeks was 54.1 in the placebo, low dose and high dose groups, respectively, %, 61.5%, and 63.2%. The disability improving effect of nelonemdaz was also found in an mRS 0 (normal) to 6 (dead) classification analysis. They found that the proportion of patients with a BI score above 90 (able to do independent activities), a measure of daily living, was 43.6% in the placebo group and 63% in the Nelonemdaz group.
Efficacy was also seen in 152 patients who received all 10 doses of the drug. In particular, the high-dose group showed a significant disability improvement effect in the analysis of mRS distribution after 4, 8, and 12 weeks, and the proportion of patients with a BI score above 90 after 12 weeks was significant (41.9% in the placebo group and 64.4% in the high-dose group) P = 0.0410), the improvement effect was confirmed, the company said.
According to the results of a phase 2 clinical trial, GNT Pharma is conducting a phase 3 clinical trial in Korea to verify the efficacy and safety of high-dose Nelonemdaz for 496 patients with severe acute stroke who underwent thrombus removal within 12 hours of onset. To date, 224 patients have been enrolled, showing a 45% enrollment rate, and the company expects all patient enrollment to be completed by March 2023.
In China, Nelonemdaz’s Phase 3 clinical trial was recently recommended by the Independent Data Monitoring Committee (IDMC) to continue clinical trials.
GNT Pharma plans to launch a stroke treatment within three years by successfully completing phase 3 clinical trials in and out of Korea.
GNT Pharma CEO Kwak Byung-joo (associate professor in the Department of Life Sciences, Yonsei University) said, “Compared to single-target brain neuroprotective drugs, the efficacy and safety of Nelonemdaz have been confirmed in stroke patients who are undergoing trauma treatment following animal models. We look forward to meaningful results.”
Nelonemdaz, developed by GNT Pharma with the support of the Ministry of Science and ICT, is a multi-target neuroprotective drug that removes free radicals produced in brain neurons.
