89bio’s pegazofermin has potential to become one of the major players in the dyslipidemia space if it is successful in Phase III clinical trials, says GlobalData, a leading data and analytics company.

The Food and Drug Administration (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. According to the analyst consensus forecast on the GlobalData Pharma Intelligence Center, the drug is expected to reach $438 million by 2028. Pegozafermin is currently the only drug being investigated by 89bio and is also in Phase II trials for non-alcoholic steatohepatitis.

Kaya Olczak, Healthcare Analyst at GlobalData, comments: “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.

“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.”