U.S. clinical-stage biopharma company 89bio, Inc. has completed enrollment in ENLIVEN, the phase 2b trial of pegozafermin for the treatment of non-alcoholic steatohepatitis (NASH).
“We are very pleased to have successfully completed enrollment of 219 total patients in ENLIVEN, a well-powered trial that builds on positive data demonstrating pegozafermin’s broad metabolic effects and favorable safety/tolerability profile,” said Hank Mansbach, chief medical officer at 89bio.
“The impressive pace of enrollment is a testament to both the high level of engagement by our clinical trial sites and our team’s strategic execution and brings us one step closer to addressing the need for new treatment options for patients suffering from NASH. We see this as a significant milestone in the pegozafermin clinical program and, building on this momentum, we expect to report topline data from ENLIVEN in the first quarter of 2023.”
89bio trial details
ENLIVEN is a multicenter, randomized, double-blind, placebo-controlled phase 2b trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. The trial enrolled a total of 219 patients who will receive either one of two weekly doses (15mg or 30mg) or an every two-week dose (44mg) of pegozafermin in a liquid formulation or placebo for 24 weeks. All patients will continue treatment in a blinded extension phase for 24 weeks for a total treatment period of 48 weeks, with some of the placebo patients re-randomized to receive pegozafermin in the extension phase.
According to Stanford Medicine, NASH is liver inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease. For some people, a buildup of fat in the liver causes no symptoms and no problems. However, for some, the fat causes inflammation and damages cells in the liver.
Those suffering from NASH can see the issues worsen, causing scarring of the liver, which leads to cirrhosis.
89bio is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of NASH and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered fibroblast growth factor 21 (FGF21) analog with glycoPEGylated technology that optimizes biological activity through an extended half-life.