Skyline Therapeutics’ Gene Therapy Candidate for Wet AMD Receives IND Clearance

Skyline Therapeutics announced that the FDA has cleared the company’s investigational new drug (IND) application for a phase 1/2a clinical trial of SKG0106, a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy for the treatment of wet age-related macular degeneration (AMD). The global phase 1 clinical trial will be initiated soon, according to the company.

SKG0106 is an investigational recombinant AAV-mediated gene therapy for ocular disease. It is composed of Skyline Therapeutics’ AAV capsid and a transgene genome-encoding anti-vascular endothelial growth factor protein.

SKG0106 has demonstrated efficacy of inhibition of intraocular neovascularization, a favorable safety profile, and durability after a single intravitreal administration in preclinical studies, stated Skyline Therapeutics.

In support of the IND application, SKG0106 GMP-grade material was produced utilizing Skyline Therapeutics’ manufacturing platform that integrates cell-line development, plasmid and viral vector process development, analytical development, and GMP production, ensuring support for the company’s preclinical and clinical programs in its pipeline, noted the company in the press release.