Ribo submits EU application for SR122
Suzhou Ribo Life Science (06938.HK) and its subsidiary Ribocure Pharmaceuticals AB have filed a Phase 1 clinical trial application in the European Union for SR122, an siRNA therapy in development for dyslipidemia, including severe hypertriglyceridemia and mixed dyslipidemia, the company said.
ApoC3 and PCSK9 together
According to the release, SR122 is a dual GalNAc conjugated siRNA that acts on ApoC3 and PCSK9 at the same time. The company said both are clinically validated pathways with complementary roles in lipid metabolism, and that addressing triglyceride-rich lipoproteins and LDL cholesterol together has the potential to produce durable changes across several lipid parameters and cardiometabolic risk factors. Ribo also said patients with mixed dyslipidemia often carry substantial residual cardiovascular risk despite available lipid-lowering therapies, and that people with severe hypertriglyceridemia face a higher risk of acute pancreatitis.
Study design
The Phase 1 trial is randomized and placebo-controlled, and will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SR122 given by subcutaneous injection to healthy participants. The company said it will be the first clinical evaluation of the dual-targeting approach in humans and will generate data to support later development.
Pipeline and company comment
Ribo said Phase 2 studies of RBD5044, which it describes as its core lipid asset and the world's second-most advanced ApoC3-targeting siRNA, are under way in Europe and China. Dr. Anders Gabrielsen, the company's chief medical officer, said knocking down both ApoC3 and PCSK9 offers synergy in reducing lipid risk in severe hypertriglyceridemia, and that Phase 1 results will guide advancement through clinical development in the intended target population.