FDA gives clearance of IND for SK0106, Skyline Therapeutics’ AAV gene therapy candidate for nAMD


This investigational new drug application was cleared for the company’s phase I/II clinical trial.

©Grispb / adobe.stock.com

This investigational new drug application was cleared for the company’s phase I/II clinical trial. (Image Credit: Grispb/Adobe Stock)

Skyline Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Phase I/IIa clinical trial of SKG0106. This AAV gene therapy is a one-time intravitreally delivered treatment of neovascular age-related macular degeneration (nAMD). The company’s global phase I clinical trial is scheduled to begin soon following this approval.

According to the press release, SKG0106 is a distinctively designed recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease. It encompasses a proprietary novel AAV capsid and a uniquely configured transgene genome encoding anti-VEGF protein. In comprehensive preclinical studies, SKG0106 has demonstrated potent efficacy of inhibition of intraocular neovascularization, a favorable safety profile, and long-lasting durability following a single intravitreal administration.

In support of the IND application, SKG0106 GMP-grade material was produced utilizing 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 programs in its pipeline.

About SKG0106

Investigational SKG0106 is a proprietary novel recombinant adeno-associated viral vector containing a uniquely configured transgene with potent inhibition effect on intraocular neovascularization, an innovative one-time intravitreally delivered AAV gene therapy that is being developed for the treatment of serious ophthalmic conditions including nAMD. Robust preclinical proof-of-concept studies validated SKG0106 as a safe and effective anti-angiogenic treatment with durable suppression of neovascular lesions at a low-dose single intravitreal injection, which results in the prevention of choroidal or retinal neovascularization and relief of retinal edema and vascular leakage.

Skyline Therapeutics Receives FDA Clearance of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration. Skyline Therapeutics. July 3, 2023. Accessed July 5, 2023. https://www.prnewswire.com/news-releases/skyline-therapeutics-receives-fda-clearance-of-ind-for-skg0106-a-novel-intravitreally-delivered-aav-gene-therapy-candidate-for-neovascular-age-related-macular-degeneration-301868856.html
Related Videos
Marion Munk, MD, PhD, presenting slides
Marion Munk, MD, PhD, presenting slides
© 2024 MJH Life Sciences

All rights reserved.