Genetipharm announced on the 15th that the number of patients enrolled in the Phase 3 clinical trial of the stroke treatment drug 'Nellonemdaz,' currently being conducted at 24 university hospitals in Korea, has reached 464, showing a progress rate of 93.5%. The company expects to complete patient enrollment by the end of April and plans to apply for product approval from the Ministry of Food and Drug Safety within this year, aiming to launch the treatment as early as the second half of next year.
Nellonemdaz, being developed by GNT Pharma as a treatment for ischemic stroke. [Photo by GNT Pharma]
Nellonemdaz, developed by Genetipharm with support from the Ministry of Science and ICT and others, is a synthetic new drug that inhibits NMDA receptor activity and removes reactive oxygen species. It is the world's first multi-target neuroprotective drug that prevents brain cell death after stroke. The NMDA (N-methyl-D-aspartate) receptor is an ionotropic glutamate receptor involved in brain development and functions such as learning and memory formation. Dysfunction of this receptor is associated with various neurological diseases and disorders.
Nellonemdaz received approval for its Phase 3 clinical trial plan from the Ministry of Food and Drug Safety in August 2021, the first of its kind in Korea, and clinical trials are being conducted at 24 university hospitals. Genetipharm is conducting Phase 3 trials on 496 patients diagnosed with moderate to severe ischemic stroke. Currently, 464 patients have been enrolled, representing 93.5% of the target, and the company expects to complete patient enrollment by the end of April at the latest.
The company explained, "In the completed Phase 2 clinical trial involving 208 stroke patients with moderate or higher severity who underwent thrombectomy within 8 hours of onset, the Nellonemdaz treatment group showed improved disability compared to the placebo group." They added, "Especially, the disability improvement effect was more pronounced in severe stroke patients who received a high dose (5250mg) of Nellonemdaz."
Previously, the results of Nellonemdaz's Phase 2 clinical trial were published in the stroke journal 'Stroke (IF 10.17)' in November last year, and the ongoing Phase 3 clinical trial protocol was published in the latest issue (January) of the 'Journal of Stroke (IF 8.631)'.
According to CMI, a global market research firm in the United States, the global market size for ischemic stroke treatments is expected to increase by more than 30%, from 11.9 trillion KRW in 2021 to 15.6 trillion KRW in 2028. Currently, the stroke treatment drug 'Edaravone,' approved and prescribed in China since 2003, recorded sales of 5.2 billion yuan (approximately 930 billion KRW) as of 2019. Edaravone is an antioxidant developed by Mitsubishi Tanabe in Japan and was approved as a stroke treatment drug in Japan in 2002.
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