We are pleased to announce that Innogen's investigational original medicine efsubaglutide alfa has received US FDA clearance to begin a clinical trial in nonalcoholic steatohepatitis (NASH). It is China's first domestically developed, independently patented, humanized, long-acting GLP-1 receptor agonist to receive FDA clearance for a NASH clinical trial.
NASH is a serious, progressive form of nonalcoholic fatty liver disease (NAFLD), caused by fat accumulation in the liver with inflammation and liver-cell injury and, in some cases, scarring. It is an important cause of end-stage liver disease, liver transplantation and liver cancer. NASH is currently among the most widespread forms of chronic liver disease worldwide. According to Frost & Sullivan, the global population with NASH rose to 350 million in 2020, including 38.7 million in China. With increasing obesity, type 2 diabetes and population aging, the Chinese NASH population is expected to exceed 50 million by 2030, while nearly 27 million Americans are expected to be affected. At present, China's drug regulator, the US FDA and the EU's EMA have not approved an effective treatment for NASH, leaving substantial unmet need.
Efsubaglutide alfa is China's first domestically developed, independently patented, humanized, long-acting GLP-1 receptor agonist, with active development in type 2 diabetes, obesity and NASH. Two Phase III T2DM studies have completed assessment of the primary efficacy endpoint during the 24-week double-blind period. HbA1c fell by up to 2.1 percentage points from baseline, significantly more than with placebo (P<0.001), with good safety and tolerability and hypoglycemia incidence below 2%. In preclinical research, efsubaglutide alfa substantially improved hepatic steatosis and reduced inflammation. A subgroup analysis of patients with NAFLD in the T2DM clinical studies found improvements in fatty liver alongside lower fasting glucose, weight and blood lipids, improved glucose tolerance and greater insulin sensitivity. Innogen founder, chairman and CEO Dr. Qinghua Wang said: “FDA clearance of the NASH IND is an important starting point for Innogen's expansion into global markets. Efsubaglutide alfa is expected to become an important treatment candidate for NASH. We will continue to advance its clinical development, aiming to provide safe, effective treatment for patients with NASH in China and worldwide.”
Innogen has long been committed to providing innovative, accessible, affordable and high-quality medicines for people with metabolic disease. We will continue to invest in research across chronic metabolic diseases and work to provide patients with better innovative medicines.