China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its drug candidate HG202, an innovative treatment for neovascular age-related macular degeneration (nAMD).
BRIGHT Study to Assess Safety and Tolerability of HG202
The upcoming BRIGHT study, an open-label, multicenter dosage escalation study, is designed to evaluate the safety and tolerability of HG202, a high fidelity CRISPR-Cas13 RNA editing therapy, in patients with nAMD. This disease impacts nearly 190 million individuals aged 60 and above globally. The primary endpoint of the trial focuses on the safety and tolerability of HG202 at varying doses following a single administration. Secondary endpoints encompass changes in best corrected visual acuity (BCVA), measurement of central retinal thickness (CRT), and the necessity for salvage injections of anti-VEGF.
HG202’s Clinical Significance in RNA Editing Therapy
HG202 marks the first CRISPR/Cas13 RNA editing therapy to reach the clinical stage and stands as the sole clinical stage RNA targeted therapy for nAMD.- Flcube.com
