27 July 2023 | Thursday | News
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The study, consisting of single ascending-dose cohort and multiple ascending-dose cohort, has dosed the first of 36 planned study subjects. The Phase I clinical trial, an open-label, multi-center, single and multiple ascending-dose study, is currently enrolling patients at multiple hospitals in South Korea, including Seoul National University Bundang Hospital.
The goal of the study is to assess safety, tolerability, MTD (maximum tolerated dose), RP2D (recommended phase 2 dose), as well as clinical efficacy and pharmacokinetics of PMC-403 in subjects with nAMD,an advanced form of macular degeneration, that results in significant central vision loss due to neovascular and non-neovascular damages.
PMC-403 is a potential 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. PharmAbcine has been developing this asset to treat not just AMD (Age-related Macular Degeneration), but also DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy). The Company also plans to further expand therapeutic scopes of PMC-403 to other systemic vessel-related diseases.
"This clinical trial is the world's first ophthalmology trial using Tie2 activation antibodies.", said Dr. Sagong Min, Professor of Yeungnam University Hospital, who conducted the first patient administration. He further added,"Tie2 activation antibody 'PMC-403,' developed by PharmAbcine, stabilizes abnormal blood vessels and reduces leakage, providing a new treatment option for patients who do not respond or have become relapsed to the existing anti-VEGF drugs."
"The initiation of the clinical trial to evaluate PMC-403's performance in nAMD is a significant step to unlocking its full potential," said Dr. Jin-San Yoo, CEO of PharmAbcine. "There are significant unmet needs in ophthalmology field as patients, who do not respond or have become relapsed to the existing anti-VEGF drugs, have no alternative therapeutic options. Our team believes that once PMC-403 shows positive therapeutic effects in one of the most prevalent vessel-related ocular diseases, it would surely be a new game-changer in the market."
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