Visirna Announces Dosing of the First Subjects in China Phase I Study of VSA001

SHANGHAI, CHINA – May 25ᵗʰ, Visirna today announced that it has dosed the first subjects in a China Phase I clinical study of VSA001, an RNAi-based investigational medicine targeting Apolipoprotein C-III (APOC3) being developed for the treatment of hypertriglyceridemia. The Phase I, randomized, double-blind, placebo-controlled, and single-dose study (CTR20231390) is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VSA001 in healthy adult volunteers. Professor Haiyan Li, M.D., Principal Investigator at Peking University Third Hospital, said: “As a physician as well as researcher in cardiovascular disease area, we acknowledge that APOC3 has emerged as a therapeutic target for triglyceride reduction. The promising data from global studies demonstrated that VSA001 is a potential treatment for patients with Familial Chylomicronemia Syndrome (FCS) and hypertriglyceridemia. As the principal investigator of the study, I am delighted to be involved in VSA001’s first clinical study and its dosing of first subjects in China.” “The successful initiation of China Phase I study of VSA001 was achieved thanks to the volunteers and investigators. As the core program in Visirna’s pipeline, VSA001 is widely anticipated by patients with hypertriglyceridemia and physicians given its favorable safety and efficacy profile with long administration interval. To ensure VSA001’s early access to Chinese patients, we are committed to collaborating with our investigators and advancing clinical development as well as regulatory approval of VSA001 in China.” Dr. Xiaoming Zou, CEO of Visirna, said. Visirna was founded in 2022 in a strategic partnership with Arrowhead Pharmaceuticals (NASDAQ: ARWR). Based in China, with a global vision, Visirna aims to be a leading player in the research and development of oligonucleotide therapeutics. We currently have three first-in-class late clinical-stage siRNA candidates licensed from Arrowhead Pharmaceuticals for the treatment of cardiovascular and metabolic diseases. Familial chylomicronemia syndrome (FCS) is a severe and ultrarare genetic disease. It affects approximately 1 in 1,000,000 people and is often caused by various monogenic mutations. FCS leads to extremely high fasting triglyceride (TG) levels, typically over 900 mg/dL. Such severe elevations lead to various clinical disorders, including atherosclerotic cardiovascular disease, acute pancreatitis, type 2 diabetes mellitus, hepatic steatosis, etc. Currently, there are limited therapeutic options that can adequately treat FCS, which is approved by FDA.

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