South Korea-based clinical-stage biotech company PharmAbcine, Inc. (KOSDAQ: 208340) announced on Monday that it has received unanimous safety approval from the Safety Review Committee (SRC) for its TIE2-activating antibody candidate, PMC-403, 4mg single ascending dose (SAD) cohort in its Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD).
PharmAbcine is now preparing to begin enrolment for the 4mg multiple ascending dose (MAD) cohort.
This Phase 1 trial targets patients with neovascular AMD who no longer respond to anti-VEGF standard therapies. The safety and tolerability of the 4mg single dose were successfully confirmed, laying the groundwork for advancing to the multiple-dosing phase.
PMC-403 is a novel TIE2-activating antibody with a unique mechanism that stabilises pathological, leaky blood vessels. TIE2 receptors, expressed on endothelial cells, play a critical role in vessel normalisation processes such as angiogenesis and intercellular adhesion, thereby inhibiting the progression of AMD.
PharmAbcine says that it plans to continue its research with the goal of initiating a Phase 2 trial after confirming the safety and efficacy of the 4mg multiple-dose cohort. The Company expects PMC-403 to play a pivotal role in the global market for AMD treatments.
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