FDA clears investigational new drug application for wet AMD gene therapy
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The FDA granted investigational drug clearance to HG202, a CRISPR/Cas13Y RNA-editing therapy for neovascular age-related macular degeneration, according to a press release from HuidaGene.
According to the release, HG202 is the first CRISPR/Cas13Y RNA-targeting therapy in clinical development as well as the only clinical-stage CRISPR RNA-editing therapy for AMD.
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After promising results from preclinical studies, HuidaGene is initiating a phase 1 dose finding trial for the therapy.
“This open IND for HG202 by the U.S. FDA — the first regulator to have cleared CRISPR/Cas13 for clinical development — represents an important milestone for HuidaGene and the entire CRISPR gene-editing field of RNA editing,” HuidaGene co-founder and CEO Alvin Luk, PhD, MBA, CCRA, said in the release. “We chose to go to the FDA because HG202 demonstrated good results in the in vitro, in vivo preclinical studies and first-in-human SIGHT-I trial. In September 2023, we dosed the world’s first novel CRISPR/Cas13 RNA-editing therapy in humans, and we recently presented preliminary data at the ARVO, ASGCT, Euretina, and ESGCT this year. The rigor of our clinical data in China using a non-receptor binding pathway approach through Cas13 RNA editor to partially knock down the mRNA expression of VEGF-A brings the potential to AMD patients.”
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