US FDA Clears HuidaGene’s HG202 IND Application for Innovative RNA-Editing Therapy for Neovascular AMD

HuidaGene Therapeutics (HuidaGene), a global clinical-stage biotechnology company specializing in genome medicines, has announced that the US FDA has cleared its HG202 investigational new drug (IND) application for neovascular age-related macular degeneration (nAMD). HG202 stands out as the first-ever clinical-stage CRISPR/Cas13 RNA-editing and the only RNA-targeting therapy for nAMD, marking a significant milestone in treating this condition.

Publish Date: 04-11-2024 Source: HuidaGene Therapeutics

Neovascular age-related macular degeneration (nAMD) represents one of the leading causes of blindness globally, with its prevalence projected to rise in conjunction with the aging population in various countries. The pathogenesis of nAMD is characterized by abnormal angiogenesis and macular neovascularization (MNV), also referred to as choroidal neovascularization (CNV), along with vascular leakage, hemorrhage, and scarring, which collectively contribute to irreversible vision loss. Various mediators are implicated in this multifaceted process, including kinases, cytokines, and growth factors, with the vascular endothelial growth factor (VEGF) and its receptors (VEGFRs) being the most prominent. The advent of anti-VEGF agents, such as ranibizumab, bevacizumab, aflibercept, brolucizumab, and faricimab, has significantly transformed the clinical management of nAMD. However, an unmet clinical need persists for novel and enhanced therapies, as many patients exhibit suboptimal responses, experience a loss of efficacy over time, or require more durable treatment options, which affects real-world outcomes.

It is estimated that approximately 1 in 10 individuals with any signs of age-related macular degeneration (AMD) will develop nAMD.

However, the current Neovascular Age-Related Macular Degeneration (nAMD) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (OLX10212, Aflibercept, CLS-AX, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Neovascular Age-Related Macular Degeneration (nAMD) treatment. The key companies in the advanced development stage are Olix Pharmaceuticals, Inc., Cinnagen, Clearside Biomedical, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Neovascular Age-Related Macular Degeneration (nAMD) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.