The latest in clinical trial development comes to the forefront as 89bio Inc., a premier clinical-stage biopharmaceutical company, recently initiated the Phase 3 ENLIGHTEN-Cirrhosis study of pegozafermin. This trial is a ground-breaking first-step in the pursuit of advanced therapies for Metabolic Dysfunction-Associated Steatohepatitis (MASH) patients with compensated cirrhosis (F4). The pegozafermin has made history as the first fibroblast growth factor 21 (FGF21) analog introduced into a Phase 3 testing stage for MASH.
Primarily addressing Nonalcoholic Steatohepatitis (NASH), 89bio Inc. has additionally implemented a strategic alignment with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to pave the way for a Phase 3 program for pegozafermin. This program aims to encompass both F4 and F2-F3 NASH patients, with the initiation planned to occur in the first half of 2024. The development strategy for NASH includes further exploration of an accelerated approval pathway using histology as its main metric to study the disease.
Stemming from its strategic development plan, 89bio Inc. has successfully disclosed new long-term data emanating from the Phase 2b ENLIVEN trial of pegozafermin. The assessments made at the end of the trial’s 48th week demonstrated that the treatment with pegozafermin induced sustained and statistically significant improvements across several critical measures. These parameters comprised liver fat reduction alongside enhancements in non-invasive tests (NITs) determining liver injury/inflammation and fibrosis in NASH patients marked with F2-F3 fibrosis stages.
These advancements made in pegozafermin trials present a burgeoning glimmer of hope in the therapeutic field addressing MASH and NASH. Furthermore, setting a prominent stepping stone in turning around the landscape of advanced disease treatments, 89bio Inc.’s trials will arguably define and lead the next wave of potent therapeutic strategies in the forthcoming years. With the leaning in toward advanced stages of the trials, the results collected would determine the potential impact of pegozafermin on the evolving framework of Steatohepatitis treatment modalities.
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