Genetipharma announced on the 11th that it has completed patient enrollment for the Phase 3 clinical trial of 'Nellonemdaz,' a drug under development for stroke treatment. The observation of the last patient who received the drug is expected to be completed by early July, with the main clinical results planned to be disclosed in the fourth quarter.
Genetipharma stated, "As the clinical trial progressed smoothly at stroke centers in 24 university hospitals nationwide, the administration to the last patient was completed more than a year earlier than the initially scheduled June next year. We plan to launch the treatment in the second half of next year depending on the Phase 3 clinical trial results."
Nellonemdaz is a multi-target neuroprotective drug that inhibits N-methyl-D-aspartate (NMDA) receptor activity while simultaneously removing reactive oxygen species to prevent brain cell death after stroke. This Phase 3 clinical trial is conducted to verify the disability improvement effect of Nellonemdaz in severe stroke patients undergoing intra-arterial thrombectomy within 12 hours. Enrollment of the targeted 496 patients has been completed.
Stroke is a disease in which blood vessels to the brain are blocked or ruptured, causing brain cells to die. Globally, 15 million patients occur annually. Thrombectomy has been successfully introduced as a recanalization treatment for stroke patients. Genetipharma previously conducted a Phase 2 clinical trial of the neuroprotective drug on 209 stroke patients who underwent thrombectomy within 8 hours. As a result, safety and disability improvement effects were confirmed in stroke patients administered low-dose 2750 mg or high-dose 5250 mg of Nellonemdaz for 5 days. Notably, among severe stroke patients who received the high dose, the proportion of patients without disability symptoms and those capable of independent activities significantly increased after 90 days.
The primary efficacy endpoint of this Phase 3 clinical trial is set as the distribution of scores on the modified Rankin Scale (mRS), which assesses disability in stroke patients, to verify the disability improvement effect. Secondary efficacy endpoints include verifying the drug's effect compared to placebo by ▲increased proportion of patients capable of independent activities ▲increased proportion of patients without disability symptoms ▲prevention of cerebral infarction ▲prevention of symptomatic cerebral hemorrhage (a major side effect of thrombectomy).
Byung-Joo Kwak, CEO of Genetipharma (also an adjunct professor at Yonsei University's Department of Life Sciences), said, "Following the completion of patient enrollment for the Phase 2 clinical trial verifying the ischemic brain injury prevention effect in cardiac arrest patients whose spontaneous circulation was restored within 4 hours last month, we have now completed patient enrollment for the Phase 3 clinical trial targeting local cerebral ischemia patients who underwent thrombectomy. This enables us to broadly verify the efficacy and safety of Nellonemdaz according to stroke types within this year." He added, "Since the safety and efficacy of Nellonemdaz were confirmed in the Phase 2 stroke clinical trial, we expect the efficacy of Nellonemdaz to be verified in both the cardiac arrest Phase 2 and stroke Phase 3 clinical trials. The main results of the clinical trials will be available in the fourth quarter."
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