#Israel #Tel Aviv #Galmed Pharmaceuticals #Aramchol #Blood Markers

Galmed Pharmaceuticals Introduces Innovative Blood Markers for Aramchol

In a significant development in the world of biopharmaceuticals, Galmed Pharmaceuticals Ltd. has unveiled groundbreaking pharmacodynamic (PD) blood markers tied to Aramchol, its leading SCD1 inhibitor. This advancement follows a comprehensive analysis of blood samples from participants in the ARMOR (Phase 3 MASH Study), which examined the therapeutic effects of Aramchol and has led to key insights into its biochemical and physiological impacts.

The novel blood markers reveal a distinct pharmacodynamic signature associated with Aramchol usage. This signature demonstrates a reduction in chronic systemic inflammation as well as oxidative and cardiac stress indicators. Furthermore, it highlights an impressive decrease in the level of Atrial Natriuretic Peptide (ANP)—a clinically validated marker signaling heart failure. These discoveries elevate Aramchol's profile, underscoring its potential far beyond treating non-alcoholic steatohepatitis (NASH), fostering interest in broader cardiometabolic and oncological applications.

Collaborative Approach to Biomarker Development

Galmed's initiative in discovering these important biomarkers arose in partnership with Proteas Health, a company recognized for its expertise in protein biomarker and targeted assay technology. Utilizing cutting-edge proteomics and artificial intelligence, the team identified a panel of 70 proteins expressed at the 12-week mark of Aramchol treatment. This panel is poised to facilitate a singular blood-based PD signature that physicians can use to monitor and potentially predict patient responses, reflecting both systemic and localized effects on the liver.

The findings are revealing; they align with the reduction of chronic inflammation, oxidative stress, and factors associated with atherosclerotic plaque formation. This progress is crucial, as these are vital contributors to cardiometabolic diseases.

Implications for Clinical Development

Allen Baharaff, CEO of Galmed, expressed enthusiasm regarding these discoveries, remarking, "The newly discovered markers indicate significant expression changes in untreated patients, providing a promising tool for gauging Aramchol's efficacy in clinical settings. The marked impact on cardiometabolic biomarkers paves the way for Aramchol's exploration in cardiovascular diseases and related conditions."

The collaborative effort aims to translate these findings into a cost-effective, high-throughput assay that measures Aramchol's unique PD signature effectively. Once validated, this assay will strengthen future clinical trials, enabling researchers and clinicians to assess drug responses in real time, thereby minimizing the risks associated with drug development.

Dr. Antigoni Manousopoulou, Co-Founder and Chief Scientific Officer at Proteas Health, added, "This endeavor aims to enhance drug development by innovatively utilizing pharmacodynamic biomarkers to ensure therapies are tailored for optimal benefits with minimal risks."

A Promising Future for Aramchol

As Galmed Pharmaceuticals capitalizes on this momentum, it maintains a strong position in expanding its clinical pipeline. The research enhances Aramchol’s safety and efficacy profile, suggesting it might fulfill unmet medical needs within cardiometabolic and oncology domains. Notably, the capability to demonstrate and monitor Aramchol's effects through a singular blood test could reshape clinical development paths and open avenues for commercialization across diverse therapeutic areas.

Galmed’s concerted efforts underscore the company's commitment to advancing Aramchol for treating liver and cardiometabolic conditions, signifying a pivotal moment of growth and innovation in the pharmaceutical landscape. With the ongoing burden of these health conditions, unveiling Aramchol's pharmacodynamic potential holds transformative promise for clinical applications and improved patient outcomes.