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Skyline Therapeutics Obtains FDA Clearance for SKG0106, an Intravitreal AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration

Monday, July 03, 2023

Skyline Therapeutics, a gene therapy company dedicated to addressing rare and severe diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for SKG0106. This IND clearance allows the company to proceed with Phase I/IIa clinical trials of SKG0106, an intravitreally delivered AAV gene therapy candidate for the treatment of neovascular age-related macular degeneration (nAMD). The global Phase I trial will commence soon.

SKG0106 is a unique recombinant adeno-associated virus (AAV) gene therapy designed for ocular diseases. It incorporates a proprietary AAV capsid and a transgene genome encoding an anti-VEGF protein. Preclinical studies have shown that SKG0106 exhibits potent efficacy in inhibiting intraocular neovascularization, along with a favorable safety profile and long-lasting effects after a single intravitreal administration.

The IND application was supported by the production of GMP-grade material for SKG0106, utilizing Skyline Therapeutics' proprietary manufacturing platform. This platform integrates various processes such as cell line development, plasmid and viral vector process development, analytical development, and GMP production, ensuring robust support for the company's preclinical and clinical programs.

SKG0106 is being developed as a one-time intravitreal AAV gene therapy for serious ophthalmic conditions, including nAMD. Preclinical proof-of-concept studies have demonstrated its efficacy in suppressing neovascular lesions, preventing choroidal or retinal neovascularization, and reducing retinal edema and vascular leakage.

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