GM-60106 / JD Biosci - LARVOL DELTA

GM60106: A NOVEL CLINICAL TREATMENT FOR METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) (AASLD 2025) - P1 | "GM-60106 demonstrated significant efficacy in preclinical models by mitigating lipid accumulation, inflammation, and fibrosis, outperforming current alternatives like Resmetirom. The Phase 1 clinical study further validated its safety and tolerability, highlighting GM-60106 as a promising candidate for long-term treatment strategies aimed at addressing the unmet needs of patients with MASLD. These findings support the continued clinical development of GM-60106 as a potentially first-in-class therapeutic candidate for the treatment of MASLD/MASH."

Clinical • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • HTR2A

GM-60106, a novel 5-HT2a antagonist improves MASLD and fibrosis with a safe phase 1 profile (EASD 2025) - P1 | "In the STZHFD model, efficacy was compared to the thyroid hormone receptor-β agonist Resmetirom. GM-60106, a novel peripheral 5-HT2A antagonist, shows strong therapeutic potential for MASLD by targeting serotonin-mediated hepatic steatosis and fibrogenesis. It demonstrated robust efficacy in multiple preclinical models and was safe and well-tolerated in healthy volunteers and MASLD patients in a Phase 1 trial. These results support GM-60106 as a first-in-class oral candidate for MASLD/MASH and warrant further clinical evaluation in populations with metabolic disease, including type 2 diabetes."

P1 data • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

JD Biosciences, MASH Treatment 'GM-60106' Phase 2a FDA Approval [Google translation] (HIT News) - "JD Bioscience announced on the 9th that it received approval for an investigational new drug (IND) phase 2a clinical trial plan from the U.S. Food and Drug Administration (FDA) for 'GM-60106', a new drug candidate for the treatment of metabolic abnormality-associated steatohepatitis (MASH)....The trial will be conducted in a 12-week, randomized, double-blind, placebo-controlled manner with 90 MASH patients in the United States."

IND • New P2a trial • Metabolic Dysfunction-Associated Steatohepatitis

A NOVEL HTR2A ANTAGONIST FOR THE TREATMENT OF METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE (AASLD 2024) - P1 | "HTR2A knockout in hepatocytes reduced lipid accumulation, inflammation, and hepatocyte ballooning, while HTR2A knockout in hepatic stellate cells decreased fibrosis across several mouse models. In a preclinical study, GM-60106, a novel HTR2A antagonist, reduced MASLD progression at multiple levels and effectively reduced hepatic fibrosis. In the phase 1 clinical trial, GM-60106 was found to be safe and well-tolerated, with optimal PK profiles for oral administration."

Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • HTR2A

GM-60106 (a peripheral 5HT2A antagonist) as a clinical candidate for metabolic dysfunction-associated steatohepatitis (MASH) (EASL-ILC 2024) - P1 | "In the first-in-human clinical trial, GM-60106, a novel HTR2A antagonist, has been determined to be safe and well-tolerated, displaying PK profiles optimal for oral administration. A multiple ascending dose study is currently ongoing to assess the safety, PK, and PD of the compound, paving the way for further long-term toxicity assessments and human proof-of-concept studies to establish the potential of GM-60106 as a promising treatment for MASH."

Clinical • Late-breaking abstract • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Oncology • Solid Tumor • HTR2A

GM-60106, A NOVEL DRUG CANDIDATE FOR NON-ALCOHOLIC STEATOSIS (NASH) (AASLD 2022) - "GM-60106 is a first-in-class drug candidate for NASH, since it is an antagonist for the novel target HTR2A that is directly connected to fibrosis and correlated steatosis. Preclinical and toxicology studies were completed and showed that the compound can improve both hepatosteatosis and liver fibrosis and is not permeable to BBB; thus, it does not induce any CNS-mediated safety concerns. Conclusively, the novel mechanism for liver fibrosis and superior pharmacokinetics can differentiate GM-60106 from other current clinical drug candidates for NASH."

Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Non-alcoholic Steatohepatitis

First-in-Human Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease (clinicaltrials.gov) - P1 | N=96 | Enrolling by invitation | Sponsor: JD Bioscience Inc.

New P1 trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis