Aramchol (aramchol meglumine) / Galmed, Weizmann Institute of Science - LARVOL DELTA

Galmed Announces Grant of New Use Patents for the combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for MASH (Galmed Pharma Press Release) - "The new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042....The patent covers the use of a combination therapy of Aramchol and Rezdiffra (MGL-3196, resmetirom) for the treatment of non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis in South Korea."

Patent • Metabolic Dysfunction-Associated Steatohepatitis

Novel MAFG-METTL14-SCD1 axis regulates lipid metabolism mediating choroidal melanoma distant metastasis. (PubMed, J Exp Clin Cancer Res) - "Our study identifies SCD1-mediated lipid remodeling as a key driver of enhanced membrane fluidity and metastatic potential in CM. Inhibition of SCD1 increases lipid saturation, reduces membrane fluidity, induces oxidative stress, and suppresses liver and lung metastasis. The MAFG-METTL14-SCD1 axis thus represents a critical regulator of CM progression, and combined therapeutic targeting with aramchol and S-HFD offers promising translational potential."

Journal • Choroidal Melanomas • Melanoma • Metabolic Disorders • Ocular Melanoma • Oncology • Solid Tumor • METTL14

Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Galmed Pharmaceuticals Ltd

New P1 trial

Galmed Announces Top-line Results in Oncology MoA Studies: A 3-drug combination of Aramchol, Stivarga and Metformin Significantly Enhanced GI Tumor Cells, Killing In-vivo and In-vitro (Galmed Pharma Press Release) - "In addition, Regorafenib and Aramchol interacted to suppress tumor growth in hepatoma models without normal tissue toxicities. Today's announced top line results include new data regarding the synergetic effects of Aramchol and Stivarga with Metformin. In this latest study, Aramchol demonstrated the mechanism of action of Aramchol's anti-tumor abilities, alone or when combined with the mutli-kinase inhibitor regorafenib and the type 2 diabetes drug, Metformin, suggesting a synergistic effect and potential for fixed dose combination for treatment....'We are looking forward to initiating our Phase 1b study at VCU Massey Comprehensive Cancer Center, which is expected to commence in early 2026. This Phase 1b study will also serve as a proof-of-concept on Aramchol's efficacy in an oncology clinical setting.'"

New P1 trial • Preclinical • Cholangiocarcinoma • Colorectal Cancer • Hepatocellular Cancer

Galmed Pharmaceuticals…announced meaningful top-line results from Galmed's AM-001 Study, a Phase 1 Bioavailability (BA) Study of Aramchol meglumine (PRNewswire) - "The AM-001 study was designed to help identify the optimal doses for advancing Aramchol meglumine into the upcoming oncology Phase 2 studies planned for H1 2026. The study compared the relative BA of Aramchol meglumine granules to Aramchol free acid tablets in 30 healthy volunteers. The study results demonstrated that the BA of Aramchol from the Aramchol meglumine granules is considerably greater than that from Aramchol free acid tablets. The BA of 400mg and 200mg Aramchol meglumine granules were approximately 5-fold and 3-fold respectively, from that of the Aramchol free acid 300 mg tablets."

New P2 trial • P1 data • Solid Tumor

New patent applications (US 63/786,370 and US 63/915,832) have been submitted to USPTO. (Galmed Pharma Press Release)

Patent • Cholangiocarcinoma • Colorectal Cancer • Hepatocellular Cancer

Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Galmed Pharmaceuticals Ltd | Trial completion date: May 2025 ➔ Dec 2025

Trial completion date

Targeting Stearoyl-CoA Desaturase‑1 (SCD1) by the Drug-Nutraceutical Combination of Montelukast and Bixin in Ameliorating Steatotic NAFLD. (PubMed, ACS Omega) - "The combination treatment showed a significant reduction of 21.64% (P < 0.05) in lipid accumulation relative to individual treatment with Bixin or Montelukast and was comparable with the reference drug Aramchol (21.83%). The markers of oxidative stress were also significantly reduced (P < 0.05), evidenced by decreased MDA (42.25%), RNS levels (32.59%), and ROS levels (30.72%) in the combination group. These findings suggest that Bixin and Montelukast in combination hold potential for managing the multiple aspects in the pathophysiology of NAFLD development and progression."

Journal • Fibrosis • Hepatology • Immunology • Liver Cancer • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Solid Tumor • SCD

The SCD1 inhibitor aramchol interacts with regorafenib to kill GI tumor cells in vitro and in vivo. (PubMed, Oncotarget) - "Aramchol interacted with the multi-kinase inhibitors sorafenib, regorafenib or lenvatinib, to kill GI tumor cells, with regorafenib exhibiting the greatest effect. Knock down of Beclin1 reduced the lethality of regorafenib and aramchol as single agents and when combined whereas knock down of LAMP2 or BID did not reduce killing caused by aramchol as a single agent but did reduce the lethality of regorafenib alone and regorafenib plus aramchol. In vivo using the HuH7 adult hepatoma cell line, regorafenib and aramchol interacted to suppress tumor growth without normal tissue toxicities."

Journal • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • AMPK • ATG16L1 • BECN1 • HSPA5 • LAMP2 • SCD

Aramchol attenuates fibrosis in mouse models of biliary fibrosis and blocks the TGFβ-induced fibroinflammatory mediators in cholangiocytes. (PubMed, Hepatol Commun) - "Aramchol attenuates and prevents biliary fibrosis in mouse models of cholestatic liver disease by inhibiting TGFβ-induced fibroinflammatory mediators and activating PPARa/γ in cholangiocytes. These findings, combined with its favorable clinical safety profile, support the potential of Aramchol as a therapeutic candidate for PSC."

Journal • Preclinical • Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • ABCB4 • IL6 • PDGFB • PPARA • SCD • TGFB1 • TNFA

A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Galmed Pharmaceuticals Ltd | N=24 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal

Galmed Identifies Proprietary Biomarker Signature for Aramchol, Unlocking Multi-Billion-Dollar Expansion Potential Beyond NASH (PRNewswire) - P3 | N=157 | ARMOR (NCT04104321) | Sponsor: Galmed Research and Development, Ltd. | "Galmed Pharmaceuticals Ltd... announced a major scientific and strategic milestone: the discovery of a proprietary pharmacodynamic (PD) blood-based biomarker signature for its lead candidate, Aramchol — the industry's most clinically advanced stearoyl-CoA desaturase 1 (SCD1) inhibitor....70-Protein PD Signature: Identified through advanced proteomics and AI in collaboration with Proteas Health, a leader in precision biomarker development. This signature was observed at Week 12 post-treatment in the ARMOR trial. Reduction in Systemic Inflammation & Cardiac Stress: Biomarker shifts reflect decreases in key drivers of chronic inflammation, oxidative stress, and atherosclerotic plaque formation."

Biomarker • P3 data • Metabolic Dysfunction-Associated Steatohepatitis

Galmed Reports Significant Anti-Fibrotic Effects of Aramchol in PSC Models (Galmed Pharma Press Release) - "Galmed Pharmaceuticals Ltd...announced today results showing significant effects of Aramchol in pre-clinical models of primary sclerosing cholangitis (PSC)....Aramchol, an SCD-1 inhibitor, both attenuated and prevented biliary fibrosis in mouse models of PSC. Aramchol significantly reduced, in a dose-dependent manner, the increased expression of the fibrotic marker plasminogen activator inhibitor-1 and hepatic stellate cell-activating genes (VEGFA and PDGFB) in TGFβ-activated transformed human cholangiocyte cells (H69) and mouse large biliary epithelial cells (MLEs). Aramchol led to a significant inhibition of TGFβ-induced hepatic fibrosis pathways while upregulating peroxisome proliferator activated receptor (PPAR) signaling."

Preclinical • Primary Biliary Cholangitis

Galmed Announces First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer’s Regorafenib Effect in GI Cancer Models (PRNewswire) - "Results from studies at Virginia Commonwealth University (VCU) show that an Aramchol and Bayer's Regorafenib drug combination significantly reduced hepatic tumor growth in mice models. The cell killing effect in-vitro and in-vivo was due to increased autophagy and death receptor signaling. A Phase 1b Study of the addition of Aramchol to Regorafenib in patients with advanced GI cancers is planned to be initiated at VCU's Massey Cancer Center in Q4 2025."

P1 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer

Galmed Pharma Shares Jump 10% On Cancer Drug Data: Retail Traders Turn ‘Extremely Bullish’ (MSN News) - "Galmed Pharmaceuticals (GLMD) shares rose sharply on Tuesday after the company reported positive preclinical data showing that its experimental drug Aramchol enhances the effectiveness of Regorafenib in liver and colon cancer models. Following the announcement, Galmed's stock rose by 10.6%, closing at $1.46 per share."

Commercial • Colon Cancer • Colorectal Cancer

Galmed Announces First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's Regorafenib Effect in GI Cancer Models (PRNewswire) - "Results from studies at Virginia Commonwealth University (VCU) show that an Aramchol and Bayer's Regorafenib drug combination significantly reduced hepatic tumor growth in mice models; The cell killing effect in-vitro and in-vivo was due to increased autophagy and death receptor signaling; A Phase 1b Study of the addition of Aramchol to Regorafenib in patients with advanced GI cancers is planned to be initiated at VCU's Massey Cancer Center in Q4 2025."

New P1 trial • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer

Galmed Pharmaceuticals Launches VCU Collaboration to Tackle Drug Resistance in GI Cancers (Galmed Pharma Press Release) - "Galmed Pharmaceuticals Ltd...announced a sponsored research collaboration with Virginia Commonwealth University (VCU) to investigate Aramchol's potential in overcoming drug resistance in gastrointestinal (GI) cancers. Under the Sponsored Project Agreement, VCU scientists will study Aramchol in preclinical models of advanced GI malignancies – focusing on colorectal and hepatocellular (liver) cancers – in combination with standard-of-care treatments. The goal is to determine whether Aramchol's novel mechanism of action can prevent or reverse resistance to therapies such as targeted kinase inhibitors and chemotherapies, thereby enhancing their efficacy against these aggressive tumors....This collaboration addresses a critical unmet need: GI cancers (including colon and liver cancers) are among the leading causes of cancer mortality worldwide, and treatment options are often limited by therapy resistance."

Commercial • Preclinical • Colon Cancer • Gastrointestinal Cancer • Liver Cancer

Galmed Unveils Novel Pharmacodynamic Blood Markers for Aramchol, the Most Clinically Advanced SCD1 Inhibitor (PRNewswire) - "Galmed Pharmaceuticals Ltd...announces the unveiling of novel pharmacodynamic (PD) blood markers for its lead compound, Aramchol, the industry's most clinically advanced SCD1 inhibitor. These newly identified biomarkers shed fresh light on Aramchol's potential far beyond its role in NASH (MASH) therapy—offering a deeper understanding of the drug candidate's biochemical impact and presenting an exciting opportunity to enhance clinical decision-making and expand into additional disease areas....Galmed's analysis revealed that this signature aligns with reduced chronic systemic inflammation, oxidative stress, and atherosclerotic plaque pathogenesis—key drivers in cardiometabolic diseases. Significantly, the data also demonstrate a marked reduction in ANP (Atrial Natriuretic Peptide), widely recognized as an established clinical biomarker for heart failure and left ventricular dysfunction. Moreover, the findings indicate a stimulated..."

Clinical • Cardiovascular • Fibrosis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Galmed Announces Positive Part 1 Results from the AM-001 Study of Aramchol Meglumine, an Enhanced Formulation of the Most Clinically Advanced SCD1 Inhibitor (Galmed Pharma Press Release) - P1 | N=16 | NCT06502561 | Sponsor: Galmed Pharmaceuticals Ltd | "The AM-001 study was conducted in response to that FDA request and is also designed to help identify the doses best suited for advancing Aramchol Meglumine into Phase 2 studies. It consists of two parts, comparing single doses of Aramchol acid and Aramchol Meglumine in healthy volunteers. Part 2 of the study is anticipated to conclude in the second half of 2025....In Part 1 of AM-001, preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets. Based on these outcomes, 200 mg once daily appears to be the optimal dose for subsequent clinical trials. This once-daily regimen not only simplifies patient adherence (moving from twice-daily to once-daily) but is also expected to reduce the overall cost of goods."

P1 data • Trial status • Immunology

Galmed Pharmaceuticals Secures New Patent Grant Extending Aramchol's Patent Protection to 2039, Strengthening Leadership in NASH/MASH Combination Therapy (PRNewswire) - "Galmed Pharmaceuticals...today announced the grant of a new patent related to its lead compound, Aramchol. The patent covers the use of a combination therapy of Aramchol and Resmetirom (MGL-3196, Rezdiffra) for the treatment of non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis. With this latest patent, Galmed is strengthening and extending Aramchol's patent protection through September 2039, securing long-term market exclusivity for its novel NASH therapy....Commercial interest in NASH is surging – according to a recent report published by the international consulting firm Research Nester, the global NASH treatment market is projected to grow from about $5.2 billion in 2022 to over $48 billion by 2035, reflecting enormous unmet need and revenue opportunity."

Commercial • Patent • Fibrosis • Metabolic Dysfunction-Associated Steatohepatitis

Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Galmed Pharmaceuticals Ltd | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2025 ➔ May 2025

Enrollment closed • Trial primary completion date

Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Galmed Pharmaceuticals Ltd | Initiation date: Oct 2024 ➔ Jan 2025

Trial initiation date

A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (clinicaltrials.gov) - P3 | N=157 | Suspended | Sponsor: Galmed Research and Development, Ltd. | N=2000 ➔ 157

Enrollment change • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Aramchol attenuates fibrosis in mouse models of biliary fibrosis and blocks the TGFβ-induced fibroinflammatory mediators in cholangiocytes. (PubMed, bioRxiv) - "This effect is partially due to Aramchol inhibiting TGFβ-induced fibroinflammatory mediators in cholangiocytes by upregulating PPARα and -γ expression and activity. These findings, along with Aramchol's excellent safety profile in clinical trials, provide the rationale for assessing Aramchol in further clinical studies in patients with biliary fibrosis, particularly PSC, where a treatment is desperately needed."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Primary Biliary Cholangitis • ABCB4 • IL6 • PDGFB • PPARA • SCD • SERPINE1 • TGFB1 • TNFA

ARAMCHOL, A STEAROYL-COA DESATURASE INHIBITOR, ATTENUATES THE TGFΒ-STIMULATED FIBROINFLAMMATORY SIGNALS IN CHOLANGIOCYTE MODELS OF PRIMARY SCLEROSING CHOLANGITIS (AASLD 2024) - "Aramchol, an SCD inhibitor, attenuates the TGFβ-stimulated activation of the fibroinflammatory response in cholangiocytes partly through activating PPARγ. These findings warrant further investigation in PSC including in vivo models."

Fibrosis • Hepatology • Immunology • Inflammation • IL6 • PPARG • SCD • SERPINE1 • TGFB1