Eccogene Advances MASH Pipeline As FDA Clears Phase 2a MOSAIC Study For ECC4703 And ECC0509 Combination

Eccogene, a clinical-stage biopharmaceutical company focused on developing next-generation oral small molecule drugs for chronic cardiometabolic and inflammatory diseases, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MOSAIC, a Phase 2a clinical trial. This study will evaluate ECC4703, ECC0509, and their combination in adults with presumed metabolic dysfunction-associated steatohepatitis (MASH), a serious liver condition affecting millions of people globally.

The FDA’s clearance allows Eccogene to move forward with the MOSAIC trial, which represents an important milestone in advancing new therapeutic options for MASH. Jingye Zhou, Chief Executive Officer of Eccogene, stated that the company is pleased to begin this trial, as it explores two promising candidates designed to target the disease from different biological angles. ECC4703, a liver-targeting thyroid hormone receptor beta (THR-β) full agonist, is designed to improve efficacy and tolerability compared to existing treatments. 

Meanwhile, ECC0509 is a novel semicarbazide-sensitive amine oxidase (SSAO) inhibitor aimed at addressing the inflammatory and fibrotic processes associated with MASH. By studying both therapies individually and in combination, the MOSAIC trial seeks to understand whether these agents can offer a more effective and well-tolerated treatment for patients.

The MOSAIC study is a multicenter, randomized, double-blind, placebo-controlled Phase 2a trial that will be conducted across multiple sites in the United States. It is expected to enroll approximately 160 adults diagnosed with presumed MASH. Participants will receive treatment for 12 weeks, after which changes in liver fat content will be assessed as the study’s primary endpoint. This measure will help determine the potential of ECC4703, ECC0509, and their combination in reducing liver fat — a key indicator of improvement in MASH patients.

Through this study, Eccogene aims to advance its mission of developing innovative small molecule drugs that address unmet medical needs in chronic liver and metabolic diseases. The MOSAIC trial could provide valuable insights into a combination approach that targets both metabolic dysfunction and inflammation, paving the way for more effective therapies for MASH in the future.