Galmed Expands Activities to Cancer and Cardiometabolic Diseases

Galmed Pharmaceuticals Ltd., a biopharmaceutical company focused on fibroinflammatory conditions, has announced plans to expand its drug development initiatives. This decision follows the recent results from the Open-Label part of its Phase 3 NASH study, new scientific publications on the role of Stearoyl-CoA desaturase1 (SCD1) as a vital metabolic signaling hub, and an extended financial runway. Aramchol, the company's lead compound, is the most clinically advanced, first-in-class, SCD1 oral inhibitor, showing excellent safety with metabolic and anti-fibrotic effects in Phase 2 and Phase 3 trials.

The company aims to broaden its research and development over the next two years with two new programs. One program will explore novel Aramchol-based drug combinations to counteract resistance to standard oncological treatments for advanced colorectal and hepatic cancers. The other program will investigate new mechanisms of action to develop an Aramchol-based drug combination for treating cardiac fibrosis, a condition that can lead to heart dysfunction and failure in many cardiovascular diseases. The company plans to release new data from in-vitro and ex-vivo studies related to these programs in the fourth quarter of 2024.

Recent scientific literature underscores SCD1 inhibition as an emerging therapeutic strategy for significant cardiometabolic diseases, affecting over 60 million individuals in the United States. Combining SCD1 inhibitors with standard oncology treatments has the potential to prevent drug resistance, thereby improving the prognosis for patients with hepatocellular carcinoma (HCC), colorectal cancer, and glioma (GBM). Additionally, new research suggests a link between lipid metabolism and synucleinopathies, such as Parkinson's disease and certain forms of dementia, validating SCD1 inhibition as a neuroprotective treatment.

Allen Baharaff, President and CEO of Galmed Pharmaceuticals, emphasized the importance of the company's expanded focus. He noted that the conditions targeted by Galmed pose significant public health challenges and financial strains on healthcare providers globally. SCD1 is a critical enzyme that regulates many physiological processes, contributing to the progression of cardiovascular, cancer, and neurodegenerative diseases. Baharaff highlighted the company's two decades of development of Aramchol, the most clinically advanced SCD1 inhibitor. Recent scientific advancements identifying SCD1's role in lipid metabolism, coupled with an infusion of cash, have encouraged the company to expand its scope from liver diseases to addressing major cardiometabolic and cancer conditions in need of new therapies.

Galmed is collaborating with leading academic institutions and industry partners to accelerate its drug development processes. By employing cutting-edge methodologies such as AI data mining and proprietary "organ-on-a-chip" systems, the company aims to expedite its research and development activities.

Galmed Pharmaceuticals Ltd. is a biopharmaceutical company primarily focused on developing Aramchol for treating liver disease. The company has also been exploring Aramchol's potential for treating other fibroinflammatory and oncological conditions outside of liver disease. In collaboration with the Hebrew University, Galmed is also developing Amilo5MER, a synthetic peptide consisting of five amino acids.