On January 4, 2023, 89bio announced plans to initiate a Phase III clinical trial investigating pegozafermin for patients with severe hypertriglyceridemia in H1 2023, in a business update and outlook for 2023. If Phase III trials and anticipated FDA approval see success, GlobalData predicts 89bio will launch pegozafermin in the US by 2025 for severe hypertriglyceridemia. According to the analyst consensus forecast on the GlobalData Pharma Intelligence Center, the drug is expected to reach $438 million by 2028 and become one of the major players in the dyslipidemia space.
Severe hypertriglyceridemia is a type of dyslipidemia, a group of metabolic lipid disorders characterized by an imbalance of serum cholesterol and/or triglycerides. In patients with severe hypertriglyceridemia, greatly elevated triglyceride levels increase the risk of atherosclerotic cardiovascular disease, non-alcoholic steatohepatitis, and pancreatitis. The prevalence of severe hypertriglyceridemia is rising globally due to increasing cases of obesity, metabolic syndrome, and type 2 diabetes. Only half of patients with severe hypertriglyceridemia reach target lipid levels with currently marketed drugs, including statins and fibrates, demonstrating an unmet need for treatment options with better efficacy.
Pegozafermin is a glycopegylated fibroblast growth factor (FGF) 21 analog that binds FGF receptor 1 in the liver to directly regulate lipid metabolism and reduce hepatic lipid accumulation. In the Phase II ENTRIGUE trial completed in 2022, pegozafermin significantly reduced triglyceride levels in patients with severe hyperlipidemia, including in those with background statin and fibrate therapy. Pegozafermin additionally boasts beneficial metabolic effects, including glycemic control and suppression of liver fibrosis. The FDA recently supported the advancement of pegozafermin into two Phase III clinical trials, the first due to launch in the first half of 2023. If successful, pegozafermin has potential to address an unmet need of efficacious therapies with improved side-effect profiles for hypertriglyceridemia.
Pegozafermin is currently the only drug being investigated by 89bio, and is also in Phase II trials for non-alcoholic steatohepatitis. On January 4, 2023, 89bio secured a $100 million credit facility agreement with K2 HealthVentures to bolster its financial security and allow for strategic planning for success in pegozafermin clinical trials and drug launch.