Trial Approved in Korea for GNT Pharma's Neu200 Neuroprotection Drug in Stroke Patients Receiving Endovascular Therapy

May 16, 2016—GNT Pharma, which is based in Osan, South Korea, announced that the Korea Ministry of Food and Drug Safety has approved the company's investigational new drug application to initiate a phase 2 clinical study of Neu2000 in ischemic stroke patients receiving endovascular therapy. This new interventional treatment aims to recanalize arteries and salvage the ischemic brain within 8 hours of onset.

According to the company, Neu2000 is a first-in-class multitarget drug inhibiting both N-methyl-D-aspartate (NMDA) receptor-mediated excitotoxicity and oxidative stress, two major routes of brain cell death occurring in stroke. The drug shows better efficacy and therapeutic time windows than NMDA antagonists or antioxidants alone in animal models of brain ischemia. Human safety of single and multiple ascending doses of Neu2000 has been demonstrated beyond therapeutic target doses in two phase 1 studies, including 165 healthy young and elderly volunteer patients in the United States and China. GNT Pharma expects to initiate the phase 2 clinical trial during the second quarter of 2016.

The company advised that the phase 2 ENIS I study is a double-blinded, randomized, placebo-controlled, multicenter trial designed to evaluate efficacy and safety of Neu2000 for ischemic stroke patients. For the proof-of-concept study, 204 ischemic stroke patients presenting with Alberta Stroke Program Early Computed Tomography Score, or ASPECTS, ≥ 6 will be randomly assigned to receive twice-daily doses of Neu2000 or placebo for 5 days. The efficacy of Neu2000 will be evaluated by accessing neurological functions and occurrence of intracranial hemorrhage over 12 weeks. GNT Pharma expects to complete ENIS I in 2017.