•     SA030 targets ALK7, an established mechanism for addressing cardiometabolic disease

•     Phase I potential first-in-disease asset with differentiated fat-cell directed delivery

•     Targeting abdominal fat and cardiometabolic disease could significantly improve survival in people with inflammatory conditions beyond current therapies

Suzhou Siran Biotechnology Co., Ltd. (“SiranBio”) today announced a worldwide exclusive license agreement with GSK (excluding mainland China, Hong Kong, Macau and Taiwan) for SA030, a potential first-in-disease, long-acting, small interfering RNA (siRNA) oligonucleotide in development for treatment of metabolic and vascular disease. SA030 has recently entered phase I trials and targets activin receptor-like kinase 7 (ALK7), an established therapeutic mechanism for cardiometabolic disease. The programme represents broad clinical and market potential given unaddressed cardiometabolic risk across multiple chronic diseases.

Cardiometabolic disease is the leading cause of death in approximately 50% of patients with chronic kidney and liver diseases. Targeting ALK7 could reduce abdominal fat (visceral adipose tissue, VAT) while preserving lean mass, leading to improved insulin sensitivity, blood lipid profile and reduced fat cell-driven  inflammation. Growing evidence links VAT to cardiometabolic risk and lowering this in people with chronic inflammatory diseases could have a greater impact on their survival than managing the underlying disease alone.

Preclinical studies have shown a differentiated, long-acting profile for SA030 that could address the underlying inflammation associated with cardiometabolic risk through adipocyte (fat cell)-directed delivery and a low-frequency dosing schedule. SA030 has a complementary and distinct mechanism to GLP- 1 agonists and SGLT2 inhibitors, supporting potential future combination approaches to lower remaining cardiometabolic risk not fully addressed by current therapies.

Zhiwei Yang, Founder & CEO, SiranBio, said: “We are very honoured to be recognized by a top biopharma company for our cutting-edge extrahepatic delivery technology and siRNA pipeline. GSK’s  resources and clinical development capabilities have the potential to accelerate the transformation of our innovative pipeline into therapeutics, benefitting more people in the reduction of fat and related chronic diseases.”

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation (RI&I), and Head of Translational & Development Sciences, GSK, said: “Cardiometabolic disease is the leading cause of death in most patients with chronic inflammatory conditions affecting the liver, lung and kidney. This risk is driven by multiple factors, so novel complementary approaches are urgently needed. SA030 builds on our emerging pipeline targeting inflammation, fibrosis and vascular drivers of disease, and may help improve outcomes for patients.”

SA030 will benefit from GSK’s extensive expertise in oligonucleotide therapeutics, such as siRNA and antisense oligonucleotides (ASO), a key modality that could address therapeutic targets, including ALK7, that are not amenable to traditional small molecules or biologics.

Financial considerations

GSK will pay an upfront fee as well as potential future success-based development, regulatory and  commercial milestones payments up to US$1.005bn., and tiered royalties on global product net sales (excluding mainland China, Hong Kong, Macau and Taiwan).SiranBio will lead the clinical development of SA030 through the completion of phase I, following which GSK will assume responsibility for development, regulatory filings, and commercialisation outside of mainland China, Hong Kong, Macau and Taiwan.

About SiranBio

Founded in May 2022 in Suzhou China, SiranBio is a biotechnology company dedicated to the development of innovative siRNA drugs. It has developed proprietary platform technologies that cover entire process of siRNA drug discovery.  SiranBio’s SA1211 is the first dual-targeting siRNA in clinical trials in the world.  It also has world-leading technologies in siRNA adipose targeting and extrahepatic deliveries. The company has built a pipeline of nucleic acid drugs targeting antiviral, cardiovascular, and metabolic diseases, and has multiple out-licensing and collaboration programs with top pharmaceutical and biotech companies in China and abroad. Find out more at www.siranbio.com.