Eccogene Receives U.S. FDA Clearance to Initiate Phase 2a MOSAIC Trial of ECC4703 and ECC0509 for MASH

BOSTON and SHANGHAI, Oct. 06, 2025 (GLOBE NEWSWIRE) — Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MOSAIC, a Phase 2a trial evaluating ECC4703, ECC0509 and their combination in adults with presumed metabolic dysfunction-associated steatohepatitis (MASH).

“We are pleased to receive the FDA clearance to initiate our Phase 2a MOSAIC trial with ECC4703 and ECC0509 for MASH, which impacts millions of patients worldwide,” said Jingye Zhou, Chief Executive Officer of Eccogene. “As a liver targeting THR-β full agonist, ECC4703 is designed to deliver improved efficacy and tolerability compared to existing therapies. ECC0509 is our novel SSAO inhibitor engineered to address inflammatory and fibrotic pathways associated with MASH. The MOSAIC trial is designed to investigate these two individual therapies as well as their combined potential, aiming to tackle the complex challenge of MASH.”

The MOSAIC trial is a U.S.-based, multicenter, randomized, double-blind, placebo-controlled Phase 2a trial that will evaluate the efficacy and safety of ECC4703, ECC0509, and the combination of the two in adults with presumed MASH. The 12-week study is expected to enroll approximately 160 participants. The primary endpoint is change in liver fat content.

About ECC4703
ECC4703 is an oral, once-daily, selective, liver targeting full agonist of the thyroid hormone receptor beta (THR-β) in development for the treatment of metabolic dysfunction–associated steatohepatitis (MASH) and other cardiometabolic diseases. Unlike partial agonists, ECC4703 is designed to deliver greater efficacy, with the potential to achieve deeper reductions in atherogenic lipids, greater hepatic fat clearance, and favorable effects on inflammation and fibrosis improvement. In Phase 1 studies, ECC4703 demonstrated robust target engagement activities, including marked reductions in LDL-C.

About ECC0509
ECC0509 is a novel, once-daily, oral small molecule inhibitor of semicarbazide-sensitive amine oxidase (SSAO, also known as vascular adhesion protein-1 [VAP-1]), specifically engineered for high selectivity and minimal brain penetration. In a Phase 1 study, ECC0509 demonstrated dose-dependent inhibition of SSAO activity and significant changes in circulating methylamine, confirming target engagement. ECC0509 is being developed both as a monotherapy for the treatment of osteoarthritis (OA) pain and in combination with ECC4703 for MASH.

About Eccogene
Eccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for cardiometabolic and inflammatory conditions. The Company’s diverse pipeline of small molecule candidates leverages its world-class expertise in translational research, small molecule drug discovery, and a deep understanding of cardiometabolic diseases. For more information, please visit www.eccogene.com or follow the Company on LinkedIn.

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Amy Bonanno
Lyra Strategic Advisory
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