Introduction to Aramchol
Aramchol, developed by Galmed Pharmaceuticals Ltd., is a promising drug candidate primarily targeted at treating liver, metabolic, and fibro-inflammatory diseases. Here, we will delve into the recent development updates and market projections for Aramchol.
Current Development Status
Phase 3 Trials for NASH and Fibrosis
Galmed has recently published the one-year results of the Open-Label part (ARCON) of its global Phase 3 trial of Aramchol in 150 patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis, known as the ARMOR study. These results, published in the journal Hepatology, demonstrated significant histological fibrosis improvement in patients treated with Aramchol 300mg BID (twice daily)[1][4].
Clinical Development for Primary Sclerosing Cholangitis (PSC)
In addition to NASH, Galmed has initiated a clinical development program to evaluate Aramchol meglumine for the treatment of Primary Sclerosing Cholangitis (PSC), a rare chronic cholestatic liver disease. This single-arm, open-label, proof-of-concept clinical trial will assess the effects of 24 weeks of treatment in approximately 15 patients with PSC. The study will include various endpoints such as laboratory parameters, imaging, and histological fibrosis to provide a comprehensive assessment of the disease and the treatment's efficacy[3].
Expansion into Other Indications
Cancer and Cardiometabolic Diseases
Galmed is expanding its activities to include cancer and major cardiometabolic diseases. One program aims to identify novel Aramchol-based drug combinations to overcome resistance to standard-of-care oncological treatments for patients with advanced colorectal and hepatic cancers. Another program focuses on developing Aramchol-based drug combinations targeting cardiac fibrosis, which is associated with various cardiovascular diseases. New data from in-vitro and ex-vivo studies in these programs are expected to be released in the fourth quarter of 2024[5].
Market Projections
Non-Alcoholic Steatohepatitis (NASH) Market
The NASH treatment market is expected to grow significantly, driven by the increasing prevalence of the disease and the lack of approved treatments. By 2025, the NASH treatment market is estimated to be around USD 7.07 billion, with a projected growth rate of 18.2% from 2025 to 2037, reaching USD 50.5 billion by 2037. Aramchol, with its promising Phase 3 results, is well-positioned to capture a substantial share of this growing market[2].
Competitive Landscape
The NASH treatment market is highly competitive, with several drugs in various stages of development, including Vitamin E and Pioglitazone, Obeticholic Acid, Lanifibranor, Semaglutide, and Resmetirom. However, Aramchol's unique mechanism of action and its robust clinical data make it a strong contender in this space.
Expert Insights
Prof. Arun Sanyal, Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, highlighted the significant unmet need for effective therapeutics in PSC and expressed excitement about testing Aramchol's new metabolically driven therapeutic approach for this condition[3].
Allen Baharaff, CEO and President of Galmed Pharmaceuticals, emphasized the promising clinical potential of Aramchol not only for NASH and PSC but also for other fibrotic liver indications and even inflammatory bowel disease (IBD)[3].
Key Takeaways
- Clinical Success: Aramchol has shown significant histological fibrosis improvement in patients with NASH and fibrosis in Phase 3 trials.
- Expansion: Galmed is exploring Aramchol's potential in treating PSC, cancer, and cardiometabolic diseases.
- Market Growth: The NASH treatment market is projected to grow substantially, with Aramchol poised to be a major player.
- Competitive Edge: Aramchol's unique mechanism and robust clinical data position it favorably in a competitive market.
FAQs
What is Aramchol primarily used for?
Aramchol is primarily being developed for the treatment of Non-Alcoholic Steatohepatitis (NASH) and fibrosis, as well as other liver diseases such as Primary Sclerosing Cholangitis (PSC).
What are the recent clinical trial results for Aramchol in NASH?
The one-year results of the Open-Label part of the Phase 3 trial (ARMOR study) showed a high rate of subjects with histological fibrosis improvement when treated with Aramchol 300mg BID.
Is Aramchol being explored for other indications?
Yes, Galmed is expanding its activities to include the development of Aramchol for cancer and major cardiometabolic diseases, such as cardiac fibrosis.
What is the projected market size for NASH treatments by 2037?
The NASH treatment market is projected to reach USD 50.5 billion by 2037, growing at a rate of 18.2% from 2025 to 2037.
Who is collaborating with Galmed on the PSC clinical trial?
The PSC clinical trial is being conducted in collaboration with the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University.
Sources
- Galmed Pharmaceuticals Ltd. - "Galmed publishes Results from Aramchol Phase 3 Open Label part in Hepatology" - PR Newswire, September 25, 2024.
- Research Nester - "Non-alcoholic Steatohepatitis Treatment Market Forecast Report 2037".
- Galmed Pharmaceuticals Ltd. - "Galmed Announces Initiation of a Clinical Development Program to Evaluate Aramchol Meglumine for the Treatment of Primary Sclerosing Cholangitis (PSC)" - PR Newswire, May 9, 2023.
- Galmed Pharmaceuticals Ltd. - "Galmed publishes Results from Aramchol Phase 3 Open Label part in Hepatology" - PR Newswire, September 25, 2024.
- Galmed Pharmaceuticals Ltd. - "Galmed Announces an Expansion of its Activities to Cancer and major Cardiometabolic Diseases" - Investor Room, September 19, 2024.