Eccogene Receives FDA Clearance to Initiate Phase 2a MOSAIC Trial for MASH

Eccogene Receives FDA Clearance to Initiate Phase 2a MOSAIC Trial for MASH

By, Admin 8 October 2025

Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for cardiometabolic and inflammatory conditions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the MOSAIC trial. This Phase 2a study will evaluate ECC4703, ECC0509, and their combination in adults with presumed metabolic dysfunction-associated steatohepatitis (MASH).

Key Highlights

  • Regulatory Clearance: FDA approval allows Eccogene to initiate the multicenter, randomized, double-blind, placebo-controlled Phase 2a MOSAIC trial.
  • Study Design:
    - Duration: 12 weeks
    - Participants: ~160 adults with presumed MASH
    - Primary Endpoint: Change in liver fat content
    - Treatments: ECC4703, ECC0509, and combination therapy

Drug Candidates

  • ECC4703:
    - Oral, once-daily liver-targeting full agonist of thyroid hormone receptor beta (THR-ß)
    - Designed for improved efficacy and tolerability vs existing therapies
    - Phase 1 data show robust target engagement, including marked LDL-C reductions
    - Potential benefits: deeper lipid reduction, hepatic fat clearance, and improvement in inflammation and fibrosis
  • ECC0509:
    - Oral, once-daily SSAO inhibitor (vascular adhesion protein-1)
    - Engineered for high selectivity and minimal brain penetration
    - Phase 1 data demonstrate dose-dependent SSAO inhibition and target engagement
    - Developed as monotherapy for osteoarthritis pain and in combination with ECC4703 for MASH

CEO Comment

"We are pleased to receive FDA clearance to advance our Phase 2a MOSAIC trial. MASH impacts millions globally, and our two investigational therapies, both individually and in combination, aim to address the complex metabolic and inflammatory pathways underlying this disease."

  • Jingye Zhou, CEO of Eccogene.
     

About Eccogene

Eccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for cardiometabolic and inflammatory diseases. Leveraging expertise in translational research and small molecule drug discovery, Eccogene aims to deliver innovative treatments targeting high unmet medical needs.

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