GNT Pharma, a venture company specializing in new drug development, has had its stroke drug "Nelonemdaz" registered as a patent in the United States.
On June 20, GNT Pharma announced that it had received a notice of patent registration decision from the United States Patent and Trademark Office (USPTO) for the use and formulation of Nelonemdaz, a new drug designed to prevent cerebral hemorrhage and other complications following recanalization therapy in stroke patients.
This patent covers a drug therapy to prevent and reduce hemorrhagic transformation that can occur after recanalization treatments, such as administration of the thrombolytic agent "tPA" or thrombectomy, in patients with ischemic stroke. While recanalization therapy is the current standard of care for stroke patients, it can cause serious complications such as cerebral hemorrhage. Such hemorrhages are considered a major factor that significantly increases patient disability and mortality rates.
Nelonemdaz has been shown in animal models to significantly reduce cerebral hemorrhage and mortality following administration of thrombolytic agents. In actual clinical settings, the frequency of cerebral hemorrhage decreased in patients who received Nelonemdaz after thrombolytic therapy or thrombectomy.
GNT Pharma stated that the USPTO has decided to grant a patent for the use of Nelonemdaz and its derivatives to reduce cerebral hemorrhagic complications in stroke patients who have undergone recanalization therapy.
Nelonemdaz is the world's first dual-target neuroprotective drug substance developed by GNT Pharma with support from the Ministry of Science and ICT and other government agencies. As a selective NR2B NMDA receptor antagonist, it inhibits acute neuronal cell death and simultaneously eliminates reactive oxygen species, thereby blocking secondary brain cell damage.
Results from phase 2 and 3 clinical trials completed in Korea showed that patients who received Nelonemdaz promptly after arriving at the emergency room and underwent thrombectomy experienced significant improvement in disability compared to the placebo group. GNT Pharma recently submitted a multinational phase 3 clinical trial plan (IND) to confirm the efficacy of Nelonemdaz, following discussions with the Ministry of Food and Drug Safety.
Gwak Byungjoo, CEO of GNT Pharma and adjunct professor at Yonsei University's Department of Life Science, stated, "The efficacy of Nelonemdaz is being confirmed in clinical trials involving stroke patients who have received recanalization therapy," and emphasized, "This newly patented treatment method in the United States will mark a groundbreaking turning point in global stroke treatment strategies, as it can reduce the most serious side effect of recanalization therapy?cerebral hemorrhage."
GNT Pharma added, "To secure global rights and commercialization of Nelonemdaz, we are pursuing patent and clinical strategies not only in the United States but also in major markets such as China and Europe," and stated, "Based on this US patent registration, we will further solidify our position as an innovative new drug targeting the global market."
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