Skyline Therapeutics receives FDA clearance of IND for candidate for neovascular age-related macular degeneration

Betsy Goodfellow | July 5, 2023 | News story | Research and Development FDA, IND, Opthalmology, Skyline Therapeutics, neovascular age-related macular degeneration 

Skyline Therapeutics has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the phase 1/2a clinical trial of SKG0106, a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy for the treatment of neovascular age-related macular degeneration (nAMD).

It is expected that a global phase 1 trial of the drug will be initiated soon.

The drug candidate is a distinctively designed recombinant AAV (rAAV)-mediated gene therapy for ocular disease which includes a proprietary novel AAV capsid and a uniquely configured transgene genome encoding anti-VEGF protein.

In previous preclinical studies, SKG0106 has demonstrated efficacy of inhibition of intraocular neovascularisation, a positive safety profile and long-lasting durability following a single administration.

According to the company’s press release: “In support of the IND application, SKG0106 GMP-grade material was produced utilising Skyline Therapeutics’ proprietary manufacturing platform that integrates cell line development, plasmid and viral vector process development, analytical development and GMP production, ensuring unwavering support for the company’s preclinical and clinical programmes in its pipeline.”

Betsy Goodfellow

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