PharmAbcine has received approval from the Korean Ministry of Food and Drug Safety (MFDS) for its investigational new drug (IND) application, enabling the initiation of a Phase I clinical trial of PMC-403 for neovascular age-related macular degeneration (nAMD).
The single and multiple ascending-dose, multi-centre, open-label study will assess the safety and tolerability of the antibody PMC-403 in subjects with nAMD.
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It will also evaluate the maximum tolerated dose, recommended Phase II dose, clinical efficacy, and pharmacokinetics of PMC-403.
The company intends to conduct the study in several South Korea-based hospitals, including Seoul National University Bundang Hospital.
PharmAbcine CEO Dr Jin-San Yoo said: “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.”
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By GlobalDataPMC-403 normalises and stabilises pathologically leaky blood vessels by binding to TIE2 receptors, which are specifically expressed in vascular endothelial cells.
It also has the potential to treat diabetic macular oedema and diabetic retinopathy, which are the leading causes of blindness.
Last April, PharmAbcine reported that no safety issues were observed in multiple dosing groups from IND-enabling studies.
