Pharma Focus Asia

Skyline Therapeutics Announces US FDA Clearance for Phase I/IIa Clinical Trial of SKG0106

Tuesday, July 04, 2023

Skyline Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I/IIa clinical trial for their investigational new drug (IND) called SKG0106. This drug is a one-time intravitreally delivered gene therapy designed to treat neovascular age-related macular degeneration (nAMD).

SKG0106 is an innovative gene therapy that aims to inhibit intraocular neovascularization. It utilises a proprietary novel recombinant adeno-associated viral vector with a uniquely configured transgene. The therapy is administered as a one-time intravitreal injection and is being developed to address serious ophthalmic conditions, including neovascular age-related macular degeneration (nAMD).

SKG0106 makes use of a distinctively designed recombinant adeno-associated virus (rAAV) as its delivery system. It contains a proprietary novel AAV capsid and a uniquely configured transgene genome that encodes an anti-VEGF protein. This configuration allows for targeted treatment of ocular disease.

During comprehensive preclinical studies, SKG0106 demonstrated both safety and effectiveness as an anti-angiogenic treatment. It showed long-lasting suppression of neovascular lesions at a low-dose single intravitreal injection. This treatment approach effectively prevented the development of choroidal or retinal neovascularization and provided relief from retinal edema and vascular leakage.

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