Key Takeaways:
Galmed Pharmaceuticals said a combination of Aramchol and enzalutamide raised prostate cancer cell death 3-4 fold versus the drug alone in preclinical models.
"The data we present today is a result of our research work in prevention of drug resistance to blockbuster agents in oncology," Allen Baharaff, co-founder and chief executive officer at Galmed, said.
The VCaP prostate cancer cell line, sourced from a vertebral metastasis of a 59-year-old patient with metastatic prostate cancer, features high expression of wild-type androgen receptors, the clinically relevant AR-V7 splice variant and the TMPRSS2-ERG gene fusion. The interaction between the two drugs strengthened the longer they were on board, the company said.
Xtandi, marketed by Astellas Pharma and Pfizer, generated about $8 billion in global sales in 2024 and $6 billion in 2025, accounting for roughly 4 percent of Pfizer's total revenue. The main composition-of-matter patents for enzalutamide expire in 2026 in Europe and 2027 in the United States, with a U.S. price cut scheduled to begin in 2027.
Prostate cancer is the second most common cancer in men worldwide. Recent publications indicate prostate tumors adapt to standard-of-care treatments such as enzalutamide by altering lipid metabolism, and both enzalutamide-sensitive and resistant cells depend on that lipid desaturation pathway. Combining enzalutamide, an androgen receptor blocker, with Aramchol, an SCD1 inhibitor, blocks lipid synthesis and desaturation, potentially delaying drug resistance.
Galmed previously demonstrated that Aramchol synergistically interacts with docetaxel (Taxotere), a chemotherapy used across tumor types where it is approved, including prostate cancer. The results support further evaluation of Aramchol with approved prostate cancer therapies, including combining it with enzalutamide, with or without a GnRH analogue, and switching to Aramchol with docetaxel as the anti-androgen effect fades.
The company has submitted a patent application for the combination and plans to initiate discussions with potential partners. A combination of Aramchol and enzalutamide could become a lifecycle-management option for Xtandi as its U.S. price cut begins in 2027, and a differentiator for generic competitors seeking a share of the multibillion-dollar market.
The preclinical data, if validated in clinical trials, could make Aramchol a combination partner in a prostate cancer market dominated by Xtandi. Investors will watch for Galmed's next step toward clinical development and any partnership announcement.
This article is for informational purposes only and does not constitute investment advice.
