89bio, Inc. has two phase 3 studies underway, known as ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, which are using pegozafermin to target F2 — F3 and F4 compensated cirrhosis MASH patients respectively. The promise of the two ongoing phase 3 ENLIGHTEN studies is that there was alignment gained with the FDA that each could use an interim analysis endpoint for potential Accelerated Approval. The global non-alcoholic steatohepatitis market is projected to reach $24.26 billion by 2028.
89bio is a clinical-stage biopharmaceutical company that develops therapies for liver and cardiometabolic conditions. Their drug candidate, pegozafermin, has shown positive results in reducing liver fat and insulin resistance and is in phase 3 trials for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin has the potential to tap into a large market and has been granted FDA Breakthrough Therapy designation for treating MASH with fibrosis.