US-based biopharmaceutical company 89bio has begun the Phase III ENLIGHTEN-Cirrhosis clinical trial of pegozafermin for treating metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis (F4).
The randomised, placebo-controlled study aims to enrol nearly 760 patients, who will be randomly assigned in equal proportions to receive either a 30mg weekly dose of pegozafermin or a placebo.
Subjects will then self-administer pegozafermin using its commercial liquid formulation, which is designed for subcutaneous injection.
The primary endpoint for an interim analysis of fibrosis regression has been defined as an improvement from stage F4 to an earlier stage of fibrosis.
This early assessment could support expedited regulatory filings in the US and Europe for pegozafermin.
The trial will continue until several pre-determined clinical outcome events have been observed.
The study's final analysis will focus on a composite of clinical outcomes as the primary endpoint.
Its secondary endpoints include assessments using non-invasive tests (NITs) to monitor liver health and metabolic indicators.
89bio chief medical officer Hank Mansbach said: “Initiating the ENLIGHTEN-Cirrhosis trial marks a significant milestone for pegozafermin as it becomes the first FGF21 analogue to enter a Phase III trial in MASH patients with compensated cirrhosis.
“In our Phase IIb ENLIVEN trial, we observed not only improvements in key non-invasive markers of liver inflammation and fibrosis, but specific improvements in fibrosis based on histology among patients treated with pegozafermin.
“We are eager to build on these results in our comprehensive global Phase III trial involving a larger number of patients.”
Based in California, 89bio aims to develop best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options.
Earlier this year, the European Medicines Agency granted priority medicines (PRIME) status for pegozafermin to treat patients with non-cirrhotic MASH with advanced forms of fibrosis.
