Suzhou Ribo Life Science (06938.HK) and its subsidiary Ribocure Pharmaceuticals AB, collectively referred to as Ribo, announced the submission of a Phase I Clinical Trial Application (CTA) in the EU for SR122, a dual GalNAc conjugated siRNA therapeutic being developed for the treatment of dyslipidemia, including severe hypertriglyceridemia (sHTG) and mixed dyslipidemia.

Lipid Pipeline Strategy

The filing comes as Ribo progresses Phase II clinical studies of RBD5044, described as its core lipid asset and the world's second-most advanced ApoC3-targeting siRNA, in Europe and China. Ribo said the SR122 submission marks a further upgrade to its lipid pipeline strategy and a key step in solidifying its position in lipid disorders.

Dual Targeting Approach

SR122 simultaneously targets ApoC3 and PCSK9, two clinically validated pathways that Ribo says play complementary roles in lipid metabolism. By addressing both triglyceride-rich lipoproteins and low-density lipoprotein cholesterol (LDL-C), SR122 has the potential to provide a differentiated treatment approach with durable improvements across multiple lipid parameters and cardiometabolic risk factors, according to the company.

Clinical Need

Ribo states that dyslipidemia remains a major global health challenge and a key driver of cardiovascular disease, the leading cause of death worldwide. According to the company, patients with mixed dyslipidemia often continue to face substantial residual cardiovascular risk despite currently available lipid-lowering therapies, while individuals with severe hypertriglyceridemia are also at increased risk of acute pancreatitis.

Trial Design

The Phase I clinical trial is a randomized, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered SR122 in healthy participants. The study will provide the first clinical evaluation of the dual targeting SR122 approach in humans and generate key data to support further development.

Company Comment

"The simultaneous knockdown of ApoC3 and PCSK9 provides superior synergy in reducing overwhelming lipid risk in severe hypertriglyceridemia and represent a step change in patient risk management through inhibition of complementary mechanisms. The results of the Phase I trial will be guiding the further advancement through clinical development in the intended target population," said Dr. Anders Gabrielsen, Chief Medical Officer of Ribo.