Dingxin Gene Announces First Patient Dosed in Phase I/IIa Clinical Trial of RRG001 Intravitreal Injection for nAMD
RRGENER
Biopharmaceutical R&D Developer
Recently, the first gene therapy product RRG001 intravitreal injection independently developed by RRGENER was applied in a Phase I/IIa multicenter clinical study for patients with neovascular age-related macular degeneration (nAMD) at Tianjin Medical University Eye Hospital, the leading institution. The study, led by Professor Li Xiaorong, the hospital's president, successfully completed the first patient dosing. The participant showed good ocular and systemic conditions post-surgery.
The launch of RRGENER's first registered clinical trial marks a crucial step forward in the company's development. Shortly after receiving CDE clinical trial approval in November 2023 for its RRG001 gene therapy product, the company completed ethical review, project initiation, enrollment of the first patient, and dosing within just one and a half months. This demonstrates the speed of innovation. Thanks go to Dean Li’s team, the research institutions, and partners like Biyoute for their hard work and strong support. The company will continue to fully advance the clinical development of this product and looks forward to its early market launch to benefit patients worldwide!
[Regarding RRG001 Intravitreal Injection]
The investigational drug RRG001 intravitreal injection, independently developed by RRGENER, is a recombinant adeno-associated virus (rAAV) gene therapy product. The rAAV vector carries the coding gene for an engineered VEGF receptor Fc fusion protein, which is delivered to the fundus of patients with neovascular age-related macular degeneration (nAMD) via subretinal injection. It transduces retinal/choroidal layer cells to achieve sustained expression of the VEGF receptor Fc fusion protein, avoiding the drawbacks of frequent intravitreal injections required by traditional anti-VEGF drugs. Through combinative innovation, it achieves "lower dosing, single administration, long-term benefits," reducing safety risks while also lowering the treatment burden on patients. Preliminary data from investigator-initiated clinical studies (IITs) have already revealed that RRG001 intravitreal injection can achieve sustained clinical efficacy at a lower single-dose level. Subjects in the three dose-exploration studies conducted so far have shown safety and tolerability, with no serious adverse events (SAEs) reported. This study is "A Phase I/IIa clinical trial with dose escalation and dose expansion to evaluate the safety and efficacy of a single subretinal injection of RRG001 intravitreal injection in subjects with neovascular age-related macular degeneration," aiming to assess the safety, tolerability, and preliminary efficacy of RRG001 intravitreal injection in patients with neovascular age-related macular degeneration (nAMD).
E.N.D
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Disclaimer: The content is sourced from RRGENER. This article aims to share knowledge, and all content is for reference only and does not constitute any advice.