Ractigen Therapeutics Receives CDE Clearance for Phase 1 Trial of saRNA Drug RAG-1C in Proliferative Vitreoretinopathy

Mar 31, 2025 11:55 CST Updated 11:55

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Ractigen Therapeutics recently announced that the company has developedSmall Activating RNA (saRNA) Drug for the Treatment of Proliferative Vitreoretinopathy (PVR)RAG-1C has received clinical trial implied permission from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.

RAG-1C isRactigen's Second saRNA Drug Enters Clinical Trials.Previously, the company's first saRNA drugRAG-01Has received IND approval from the U.S. FDA and obtained positive preliminary efficacy and safety data in Phase 1 clinical trials conducted in Australia.

PVRA severe fibrotic complication following the repair of rhegmatogenous retinal detachment (RRD),Characterized byRetinal Pigment Epithelium (RPE) cell abnormal migration and proliferation into the vitreous cavity, forming a contractile fibrocellular membrane, leading to retinal re-detachment, and potentially resulting in severe vision loss or even blindness.Currently, vitreoretinal surgery remains the primary treatment for this disease, and there is still a significant unmet clinical need.

RAG-1C is an saRNA drug,Upregulation of Cell Cycle Negative Regulators via RNAa Mechanismp21Gene expression, thereby inhibitingProliferation and migration of RPE cells,Thereby preventing the progression of PVR. The productIntravitreal injection using Ractigen's LiCO small nucleic acid delivery system. In preclinical studies, RAG-1C demonstrated a highly significant effect in inhibiting disease progression in a rabbit PVR model.

According to the press release from Ractigen Therapeutics, this Phase 1 clinical trial is a multi-center, randomized, double-blind, dose-escalation first-in-human study aimed at evaluating RAG-1C.For the prevention of proliferative vitreoretinopathy after vitrectomySafety/Tolerability, Pharmacokinetics, and Preliminary Efficacy.

References:

[1]China's First saRNA Drug Approved for Clinical Trials! Ractigen's RAG-1C Opens a New Chapter in PVR Treatment. Retrieved Mar 28，2025, from https://mp.weixin.qq.com/s/ueqBeen2pec3-oxV3ciSmA

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