ECC0509 / Eccogene - LARVOL DELTA

A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Eccogene | Trial completion date: Oct 2026 ➔ Sep 2027 | Trial primary completion date: Oct 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • APOB

A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Eccogene | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • APOB

Eccogene Announces First Patient Enrolled in MOSAIC Phase 2a Trial Evaluating ECC4703 and ECC0509, Individually and in Combination, for the Treatment of MASH (Businesswire) - "The study will enroll approximately 160 participants, with change in liver fat content assessed by MRI-PDFF as the primary endpoint."

Trial status • Metabolic Dysfunction-Associated Steatohepatitis

A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Eccogene

New P2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • APOB

SYNERGISTIC EFFECTS OF ECC4703, A LIVER-TARGETING THRΒ FULL AGONIST, IN COMBINATION WITH ECC0509, A SELECTIVE SSAO INHIBITOR, OR SEMAGLUTIDE IN A MASH ANIMAL MODEL (AASLD 2025) - "ECC4703 has the potential to be the corner stone for combination with other mechanisms to treat MASH in humans."

Combination therapy • Preclinical • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

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

IND • New P2a trial • Metabolic Dysfunction-Associated Steatohepatitis

Integrating ECC0509 in Pain Management: Educational and Societal Impacts (Neuroscience 2024) - "The study advocates for multidisciplinary approaches, involving biochemists, educators, and policymakers, to translate scientific discoveries into practical healthcare solutions. This could improve patient outcomes and optimize treatment practices in pain management."

CNS Disorders • Pain

Ssao inhibitor attenuates inflammatory pain by regulating trpv1 in primary sensory neurons (Neuroscience 2024) - "(3) Knockout of TRPV1 prevented ECC-induced analgesic effects. Conclusion SSAO inhibitor, ECC0509, attenuates inflammatory pain via TRPV1 in primary sensory neurons."

CNS Disorders • Pain • TRPV1

FTIH Study of ECC0509 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=89 | Completed | Sponsor: Eccogene | Recruiting ➔ Completed

Trial completion • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Osteoarthritis • Pain • Rheumatology

[VIRTUAL] ECC0509, A NOVEL PERIPHERALLY DISTRIBUTED AND SELECTIVE SEMICARBAZIDE-SENSITIVE AMINO OXIDASE (SSAO) INHIBITOR FOR NASH TREATMENT (AASLD 2021) - "The clinical development of SSAO inhibitor BI 1467335 for NASH was discontinued due to interference with brain monoamine oxidase B (MAO-B)...In addition, ECC0509 has less inhibition to DAO compared to TERN-201, suggesting unlikelihood of interference with histamine metabolism . ECC0509 is a potential best-in-class SSAO inhibitor and currently in phase I clinical trial ."

Fibrosis • Hepatology • Immunology • Inflammation • Non-alcoholic Steatohepatitis • AOC3

FTIH Study of ECC0509 in Healthy Volunteers (clinicaltrials.gov) - P1; N=86; Recruiting; Sponsor: Eccanga Pty Ltd

Clinical • New P1 trial • Hepatology • Immunology • Non-alcoholic Steatohepatitis • Osteoarthritis • Pain • Rheumatology

Eccogene Announces Completed First-in-human of ECC0509 in Phase 1a Clinical Trial in Australia (PRNewswire) - "Eccogene...announced the initiation of a Phase 1a clinical trial evaluating ECC0509, an oral inhibitor of semicarbazide-sensitive amine oxidase (SSAO)/vascular adhesion protein-1 (VAP-1), as a potentially novel therapy for patients with non-alcoholic steatohepatitis (NASH) and osteoarthritis (OA) associated pain....Preliminary topline data from the clinical trial is expected in Q1 2022."

P1 data • Trial status • CNS Disorders • Non-alcoholic Steatohepatitis • Osteoarthritis • Pain