Announcement • Aug 18

Galmed Pharmaceuticals Ltd. Announces Pre-Clinical Study Results For Combination Of Aramchol And Enzalutamide In Prostatic Cancer

Galmed Pharmaceuticals Ltd. announced significant results from a pre-clinical study of a combination of Aramchol and Xtandi (enzalutamide) for prostatic cancer. Xtandi (enzalutamide) is indicated as monotherapy for the treatment of patients with non-metastatic prostate cancer (nmCSPC) at high risk of metastasis and for the treatment of patients with metastatic prostate cancer (mCSPC) who are maintaining treatment with a GnRH analogue. Global sales for Xtandi (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025, respectively. The main composition of matter patents for enzalutamide (sold as Xtandi) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274) with a U.S. price cut scheduled to begin in 2027. New data from a VCaP prostate cancer cell line that features high expression of wild-type androgen receptors, demonstrated that a combination of Aramchol with enzalutamide resulted in 3–4-fold increase in cell death compared with enzalutamide as a single agent. Prostate cancer is the second most common cancer in men worldwide and remains a significant cause of cancer-related morbidity and mortality. Androgen signaling plays a central role in the development and progression of prostate cancer. For this reason, anti-androgen therapy and related androgen axis-targeting approaches represent important modalities in the treatment of prostate cancer. Despite the availability of anti-androgen therapies, there remains a need for improved treatment regimens that may be used alone or in combination with existing anti-androgen therapies, including in patients having resistant, recurrent, advanced, metastatic, or otherwise difficult-to-treat prostate cancer. Recent publications indicate that prostate cancer tumors can adapt to SoC treatments such as enzalutamide by altering their lipid metabolism. Both enzalutamide-sensitive and resistant cells depend on this lipid desaturation pathway. Combining enzalutamide (an androgen receptor blocker) with an SCD1 inhibitor blocks this lipid synthesis and desaturation, potentially leading to decreased cell viability, and delayed development of drug resistance. The data we present demonstrate that a combination of Aramchol (an SCD1 inhibitor) with enzalutamide resulted in 3–4-fold increase in cell death (compared with enzalutamide as a single agent) and that the interaction gets stronger, the longer the drugs are on board. The VCaP prostate cancer cell line features high expression of wild-type androgen receptors, the clinically relevant AR-V7 splice variant, and the TMPRSS2-ERG gene fusion, sourced from a vertebral metastasis of a 59 year old Caucasian mCSPC patient. Previously Galmed demonstrated that Aramchol synergistically interacts with docetaxel (Taxotere) a potent, semisynthetic chemotherapy medication, to cause greater than additive killing in a whole range of tumor types where docetaxel is approved, including prostate cancer cells. The results from those studies support the further evaluation of Aramchol in combination with approved prostate cancer therapies, including combining Aramchol with enzalutamide (with or without GnRH analogue) and as the anti-androgen interaction starts to wear off, switch to a combination of Aramchol with docetaxel. Global sales for Xtandi (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025 (accounting for roughly 4% of Pfizer's total revenue). The main composition of matter patents for enzalutamide (sold as Xtandi) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274). A combination of Aramchol and enzalutamide could potentially become a lifecycle management for Xtandi in light of the U.S. price cut scheduled to begin in 2027 as well as a key differentiating factor for any generic competitor trying to capture a portion of this multibillion-dollar market. Galmed is planning to initiate discussions with potential partners based on a patent application for the combination that has been recently submitted.

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