Galmed Pharmaceuticals Ltd (Nasdaq: GLMD), an Israeli clinical-stage biopharmaceutical company focused on developing novel treatments for liver, cardiometabolic and gastrointestinal oncology indications, on Tuesday announced novel pharmacodynamic (PD) blood markers for its lead compound, Aramchol, an advanced SCD1 inhibitor.

The company said that these newly identified biomarkers shed fresh light on Aramchol's potential beyond its role in NASH (MASH) therapy, providing a deeper understanding of the drug candidate's biochemical impact and presenting an opportunity to enhance clinical decision-making and expand into additional disease areas.

In collaboration with Proteas Health, a specialist in innovative protein biomarker and targeted assay development, Galmed has pinpointed plasma markers that track Aramchol's therapeutic impact through proteomics and AI technologies. Specifically, a panel of 70 proteins expressed at Week 12 of Aramchol treatment (compared with baseline) was captured in the company's Phase 3 ARMOR MASH study. This panel forms an actionable, single blood-based pharmacodynamic signature to monitor and potentially predict patient response, encompassing both systemic and local (liver) effects.

Analysis has revealed that this signature aligns with reduced chronic systemic inflammation, oxidative stress and atherosclerotic plaque pathogenesis -- key drivers in cardiometabolic diseases. The data also demonstrated a marked reduction in ANP (Atrial Natriuretic Peptide), widely recognised as an established clinical biomarker for heart failure and left ventricular dysfunction. Additionally, the findings indicate a stimulated expression of KDM4C, a protein known to play a role in repressing liver fibrosis.

Galmed said that together, these insights underscore Aramchol's broad therapeutic relevance and create valuable opportunities for the company to expand its clinical pipeline and address additional cardiometabolic and potentially oncological indications.

Galmed's collaboration with Proteas Health aims to translate these discoveries into a streamlined, cost-efficient, high-throughput assay that directly measures Aramchol's unique PD signature. Such an assay, once validated, could bolster Galmed's forthcoming clinical trials by further de-risking development and allowing clinicians to evaluate drug response in real time.