The Korean MFDS grants IND approval for PharmAbcine’s phase I clinical trial of its novel TIE2 agonistic antibody in nAMD
PMC-403 is a first-in-class antibody that activates TIE2, a receptor specifically expressed in vascular endothelial cells. The clinical trial will take place in multiple hospitals in South Korea.
PMC-403 is a first-in-class antibody that activates TIE2, a receptor specifically expressed in vascular endothelial cells. The clinical trial will take place in multiple hospitals in South Korea. (Image Credit: Adobe Stock/SeanPavonePhoto)
PharmAbcine Inc. announced that the company received IND (Investigational New Drug) approval from the Korean MFDS (Ministry of Food and Drug Safety). This approval will allow the company to initiate a Phase I clinical trial of PMC-403, the Company's novel TIE2 agonistic antibody. The study will take place in multiple hospitals in South Korea, including Seoul National University Bundang Hospital.
The Phase I clinical trial is an open-label, multi-center, single and multiple ascending-dose study to assess safety, tolerability, MTD (maximum tolerated dose), RP2D (recommended phase 2 dose), and as well as clinical efficacy and pharmacokinetics of PMC-403 in subjects with nAMD (neovascular age-related macular degeneration).
PMC-403 is a first-in-class antibody that activates TIE2, a receptor specifically expressed in vascular endothelial cells. Once the molecule binds to the receptors, it promotes the normalization and stabilization of pathologically leaky blood vessels. The Company has been developing this asset as a new potential therapeutic drug for neovascular ocular diseases, including AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy), all of which are the leading causes of blindness.
PharmAbcine already announced that PMC-403, even with its unique mechanism, reduced the size of retinal leakages in both mouse and monkey models comparable to a control group treated with aflibercept, the best-selling anti-VEGF drug in the current market. The Company also reported no safety issues found in multiple dosing groups from IND-enabling studies in April 2022.
"We are pleased to be granted IND approval of PMC-403 for the treatment of nAMD, one of the most prevalent neovascular ocular diseases," said Dr. Jin-San Yoo, CEO of PharmAbcine. "PMC-403 marks the world's first TIE2 agonistic antibody being approved for an ophthalmology clinical trial, and we are hopeful that it will be able to provide a new therapeutic option for patients, who do not respond or have become relapsed to the existing anti-VEGF drugs. Our members are eagerly awaiting the start of this important study and start generating encouraging data."
