#Israel #Galmed Pharmaceuticals #Aramchol #Regorafenib #Ramot Gan

Galmed Pharmaceuticals Announces Late-Breaking Abstract for HEP-DART 2025 Meeting

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), a biotech company specializing in liver and cardiometabolic disorders, has recently revealed that it will present a late-breaking abstract at the prestigious HEP-DART 2025 meeting. This event, which is focused on advancing the treatment of hepatic diseases, will highlight significant new data pertaining to Galmed's innovative drug, Aramchol.

Scheduled for December 9 at 3 PM HST, the presentation will detail the findings of a study titled "Targeting SCD1 Enhances Activity of Standard of Care Regorafenib in Hepatocellular Carcinoma: Translational Rationale for a Phase 1/2 Study of the Combination of Aramchol and Regorafenib." The data elucidates the synergistic effects of combining Aramchol with Bayer's regorafenib, particularly in the treatment of hepatocellular carcinoma (HCC) and other gastrointestinal cancers.

Significance of the Findings

Prior research conducted by Galmed has demonstrated that Aramchol enhances the anti-tumor effects of regorafenib in various gastrointestinal (GI) cancer models. The inhibition of SCD1 by Aramchol appears to augment the efficacy of regorafenib through a mechanism involving the ATM-AMPK-autophagy signaling pathway. This promising scientific rationale lays the groundwork for a Phase 1/2 clinical trial aimed at exploring the effectiveness of this drug combination in treating HCC and other GI malignancies.

Once the recommended Phase 2 dose is established, the clinical trial plans to introduce a cohort for dose expansion, integrating Metformin to evaluate the efficacy of a novel three-drug combination.

Allen Baharaff, CEO of Galmed Pharmaceuticals, expressed his excitement over the acceptance of this late-breaking abstract, stating, "The significance of our data is underscored by the decision made by VCU Massey Comprehensive Cancer to initiate an investigator-initiated Phase 1/2 clinical trial of Aramchol and regorafenib in advanced GI cancers, including HCC, scheduled to start enrollment in 2026."

HEP-DART 2025 Meeting Overview

The HEP-DART meeting, initiated in 1995 as the first international conference on therapies for viral hepatitis, brings together clinicians, researchers, and industry experts to discuss advancements in drug development for various liver diseases. The 2025 meeting aims to tackle the ongoing challenges in therapeutics for conditions such as viral hepatitis, hepatic fibrosis, and HCC.

Galmed’s participation in this high-profile conference not only reinforces its commitment to innovation in liver health treatments but also reflects a broader effort to create new avenues for addressing unmet medical needs in GI cancer care.

Looking Ahead

Galmed's ongoing focus is on leveraging Aramchol in combination with existing treatments for liver diseases and advancing its applicability to oncological indications beyond NASH. The company is striving to broaden its product pipeline with additional cardiometabolic and oncology-focused innovations. The forthcoming trial results and subsequent findings at HEP-DART 2025 could pave the way for accelerated clinical pathways for Aramchol.

With investors and stakeholders closely monitoring the developments, the company is optimistic about the potential impacts of its research on both patient outcomes and shareholder value. As 2026 approaches, the results from these clinical trials, combined with data presented at the upcoming meeting, will be pivotal in determining the next steps in Aramchol’s development and its future role in the oncology landscape.