89bio reported positive topline results from ENTRIGUE Phase II trial of pegozafermin in patients with severe hypertriglyceridemia.
Bay Area-based 89bio, Inc. posted positive topline results from its Phase II ENTRIGUE study that showed pegozafermin, at the highest dose, yielded a 63% reduction in triglycerides in patients with severe hypertriglyceridemia (SHTG).
The Phase II study met its primary endpoint, providing statistically significant and clinically meaningful reductions across all dose levels. Results were consistent in patients on or not on background therapy, the company said. The data showed significant and potent reductions in atherogenic lipids and liver fat and also demonstrated improvements in liver enzymes and glycemic control markers, 89bio said.
Based on the results from the ENTRIGUE study, the company said it intends to begin a Phase III trial assessing pegozafermin in this indication in the first half of 2023. SHTG is a condition where patients have triglyceride levels more than three times the normal level.
Shortly after announcing the positive Phase II data, 89bio announced plans to offer 18,675,466 shares of its common stock in order to raise $94.5 million to support its clinical efforts. Only hours before, the company issued a press release announcing an attempt to raise $75 million through the sale of its common stock. Shares of 89bio were down more than 12% to $3.12 as of 11:30 a.m Wednesday. The company’s stock has trended downward since the beginning of 2022 when it was selling for $14.99 per share.
89bio Chief Executive Officer Rohan Palekar noted that SHTG provides a significant market opportunity for the company. Palekar said there is a large, under-served patient population because existing therapeutic options are not providing the control they need.
“We believe the results from ENTRIGUE position pegozafermin as potentially the first FGF21 analog to market and to become an important metabolic drug for treatment of cardio-metabolic and liver disease,” Palekar said in a statement.
Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21), a hormone that modulates glycemic control, steatosis, inflammation and fibrosis. In addition to SHTG, 89bio is developing the drug candidate for the treatment of non-alcoholic steatohepatitis (NASH).
Pegozafermin treatment also resulted in significant improvements compared to placebo and clinically meaningful changes on an absolute basis in non-HDL-C and apo B, which are key markers of cardiovascular risk. Patients treated across all doses with pegozafermin also demonstrated an improvement in HDL-C and no change in LDL-C vs. placebo, the company said.
Hank Mansbach, chief medical officer of 89bio, said he is “extremely pleased” with the results of the study.
“These results add to the body of evidence demonstrating pegozafermin’s unique and differentiated profile based on broad metabolic effects and a favorable safety/tolerability profile. These positive data support the advancement into a Phase III trial in SHTG based on regulatory precedent, which we plan to initiate in the first half of 2023. These results also build confidence in our ongoing Phase IIb ENLIVEN trial in NASH with data expected in the first quarter of 2023,” Mansbach said in a statement.
