Pegozafermin is under clinical development by 89Bio and currently in Phase III for Metabolic Dysfunction-Associated Steatohepatitis (MASH). According to GlobalData, Phase III drugs for Metabolic Dysfunction-Associated Steatohepatitis (MASH) have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Pegozafermin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pegozafermin overview

pegozafermin (BIO89-100) is under development for the treatment of non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease, liver cirrhosis, fibrosis and severe hypertriglyceridemia. It is a long-acting glycopegylated fibroblast growth factor 21 (FGF21) analog. The drug candidate acts by targeting FGF21R (composed of co-receptors FGFR1c, 2c and 3c and KLB). It is administered subcutaneously. It is developed based on glycopegylation technology to prolong the half-life of FGF21.

89Bio overview

89bio is a clinical-stage biopharmaceutical company. It focuses on developing medicines for the treatment of nonalcoholic steatohepatitis (NASH) and other liver and metabolic disorders. Its lead product candidate BIO89-100, a new long-acting glycopegylated fibroblast growth factor 21 (FGF21) analogue, was formulated harnessing a proprietary glycopegylation technology that helps extend the half-life and enhance the biological functioning of native FGF21, allowing for extended-interval dosing and substantial improvement in biomarkers including body weight, blood glucose, and lipids in NASH patients. 89bio acquired a pipeline of biologic and small molecule drug candidates from Teva Pharmaceuticals. OrbiMed Israel and OrbiMed US are the founding investors of 89bio. It has operations with R&D in Herzliya, Israel. 89bio is headquartered in Menlo Park, California, the US.

For a complete picture of Pegozafermin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.