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HuidaGene Therapeutics Gains FDA Clearance for First CRISPR/Cas13 RNA-Editing Therapy HG202 to Treat Macular Degeneration

NextEdge Admin

05 Nov 2024

2 min 12 sec

HuidaGene Therapeutics, a global clinical-stage biotech company, has received U.S. FDA clearance for its investigational new drug (IND) application for HG202—the world’s first CRISPR/Cas13 RNA-editing therapy aimed at treating neovascular age-related macular degeneration (nAMD). This milestone marks the first regulatory clearance for CRISPR/Cas13 in clinical development.

According to Dr. Alvin Luk, HuidaGene's Co-founder and CEO, the FDA’s clearance underscores the potential of HG202, which demonstrated promising preclinical data and success in China’s initial "SIGHT-I" trial. By using the Cas13 RNA editor, HG202 targets VEGF-A mRNA to address AMD through a unique non-receptor binding pathway.

Dr. Xin Zhang, HuidaGene’s COO and CMO, noted the pressing need for alternative nAMD treatments, as up to 46% of AMD patients exhibit poor or resistant responses to anti-VEGF therapies. The BRIGHT trial (NCT06623279) will soon begin enrolling patients, focusing on the safety and efficacy of HG202 through a dose-escalation approach.

Dr. Hui Yang, Co-founder and Chief Scientific Advisor, highlighted the role of HuidaGene's HG-PRECISE® platform, which led to the discovery and refinement of Cas13Y, a high-fidelity RNA-editing system designed for efficiency and low off-target effects.

HuidaGene is advancing an array of clinical and preclinical programs, including HG004 for RPE65-associated retinal disease, HG204 for MECP2 duplication syndrome, and HG302 for Duchenne muscular dystrophy, positioning the company as a leader in genome medicines for neurology and ophthalmology.