#Israel #oncology #Ramat Gan #Galmed Pharmaceuticals #Aramchol

Galmed Pharmaceuticals Reports Major Advancements in Cancer Treatment

Galmed Pharmaceuticals Ltd. has recently announced compelling top-line results from its oncology mechanism of action studies, showcasing the efficacy of a three-drug combination therapy involving Aramchol, Stivarga® (regorafenib), and Metformin. This synergistic effect, established through research in collaboration with Virginia Commonwealth University (VCU), highlights a significant step forward in the treatment of gastrointestinal (GI) cancers.

In these studies, the combination of Aramchol and Stivarga® was found to substantially enhance the ability to kill GI tumor cells, both in vitro and in vivo. The promising data suggests that this three-drug regimen may not only represent a novel fixed-dose combination therapy but could also serve as a strategic life-cycle intellectual property (IP) strategy as Bayer's Stivarga® approaches the expiration of its patents in the coming years.

Key Findings

The study found that Aramchol effectively enhances the action of Bayer's Stivarga®, which is already regarded as a standard third-line treatment for metastatic colorectal cancer (CRC) and advanced unresectable gastrointestinal stromal tumor (GIST). The combination therapy promises to extend the therapeutic life of Stivarga® by providing a new treatment avenue that addresses the growing issue of drug resistance amongst patients. With approximately 75% of these patients developing resistance to existing monoclonal antibody (MAB) therapies, the combination presents an urgent need for cost-effective alternatives.

Interestingly, Metformin, a drug traditionally used to manage type 2 diabetes, is included in this regimen. Its widespread availability and established safety profile make it a valuable addition to the combination. The upcoming phase 1b clinical trials slated for early 2026 at VCU will further explore its efficacy in patients with metastatic CRC, hepatocellular carcinoma (HCC), and cholangiocarcinoma, thus reinforcing the expected expansion of Galmed's product pipeline.

Insights from Leadership

Allen Baharaff, President and CEO of Galmed, expressed optimism regarding the results, stating, “The findings open up new possibilities for patients who unfortunately find themselves with limited treatment options due to high costs and drug resistance.” He also noted that the upcoming phase 1b study will not only validate Aramchol's efficacy in clinical settings but could also accelerate its development in oncology.

The excitement surrounding this research is compounded by recent market successes of Stivarga®, which has generated substantial revenue for Bayer, indicating a lucrative pathway for Galmed should the trials confirm efficacy. The potential for Aramchol to rejuvenate the lifecycle of regorafenib as a competitive alternative against forthcoming generic versions cannot be understated.

Future Directions

As the healthcare community eagerly anticipates the phase 1b results, Galmed's strategic focus on oncology signals its commitment to not only advancing the treatment of liver disease but also addressing critical needs in cancer therapeutics. The implications of successfully integrating Aramchol into established treatment protocols could dramatically enhance outcomes for patients suffering from GI cancers.

These findings represent a significant breakthrough not just for Galmed but potentially for countless patients affected by cancer around the world. Continued investment in such combination therapies may redefine standards of care, developing new hope where there was once limited efficacy.

In conclusion, Galmed Pharmaceuticals is poised for a revolutionary impact on cancer treatment through its innovative research. The synergy of Aramchol, Stivarga®, and Metformin could soon lead to a transformative approach in treating some of the most challenging forms of cancer, introducing a new era of hope for those battling these diseases.