GNT Pharma's 'Nellonemdaz' Clinical Phase 3 Exceeds 80%... "Targeting Launch in Second Half of Next Year"

GNT Pharma's New Stroke Treatment Drug 'Nellonemdaz'
[Photo by GNT Pharma]

[Asia Economy Reporter Chunhee Lee] New drug development company GNT Pharma has disclosed the results of the Phase 2 clinical trial and the progress of the Phase 3 clinical trial for ‘Nellonemdaz,’ a drug under development for stroke treatment. The company plans to complete patient enrollment around April, as the number of patients registered for the Phase 3 trial has exceeded 80% of the total recruitment target.

GNT Pharma announced on the 14th that Professor Jinsoo Lee of the Department of Neurology at Ajou University Medical Center, who is participating in the Nellonemdaz clinical trial research, presented the Phase 2 clinical trial results of Nellonemdaz, as well as the design and progress of the Phase 3 clinical trial, at the ‘2023 International Stroke Conference (ISC)’ held in Dallas, USA from the 8th to 10th. ISC is an international academic conference hosted by the American Heart Association, where stroke researchers and clinical experts worldwide share research results and collaborate to enhance understanding of stroke, develop optimal treatment technologies, and promote brain health.

In his presentation, Professor Lee introduced the mechanism of action of Nellonemdaz, the safety and disability improvement effects confirmed in the Phase 2 stroke clinical trial, and the design and progress of the Phase 3 stroke clinical trial. In the previous Phase 2 trial, among 208 patients with moderate or more severe stroke who underwent thrombectomy within 8 hours of onset, those administered Nellonemdaz showed improved disability compared to the placebo group. Notably, the disability improvement effect was more pronounced in severe stroke patients who received a high dose (total 5250 mg).

The Phase 3 trial is designed to include a total of 496 patients who underwent thrombectomy within 12 hours, increasing the proportion of severe patients through initial CT and MRI image readings. The primary endpoint for Nellonemdaz’s disability improvement effect is designed to evaluate the distribution of scores on the modified Rankin Scale (mRS), which assesses stroke patient disability 90 days after drug administration. The secondary efficacy evaluation includes analysis of MRI or CT images taken 7 and 35 days after administration to verify Nellonemdaz’s neuroprotective effects. Professor Lee stated, “With the advancement of intra-arterial thrombectomy increasing reperfusion rates, there is a renewed trend in developing neuroprotective agents for this purpose.”

The Phase 3 trial is currently being conducted at 24 university hospital stroke centers, including the principal clinical trial center, Seoul Asan Medical Center, in South Korea. So far, 425 patients have been enrolled, showing a progress rate of 85.7%.

Byungjoo Kwak, CEO of GNT Pharma (also an adjunct professor in the Department of Life Sciences at Yonsei University), said, “Since Nellonemdaz demonstrated excellent efficacy and safety in the Phase 2 trial, we expect a high likelihood of success in the Phase 3 trial as well. With patient enrollment for the Phase 3 trial expected to be completed around April, the stroke treatment drug Nellonemdaz could be launched as early as the second half of next year.”