Galmed Announces Grant of New Patent for the Combination of Aramchol with Resmetirom (MGL-3196, REZDIFFRA) for the Treatment of NASH and Liver Fibrosis

Rhea-AI Summary

Galmed Pharmaceuticals (GLMD) secures a European patent for Aramchol and Resmetirom combination therapy for NASH/MASH and liver fibrosis, extending patent protection until 2039. The company aims to address multiple liver pathologies with a unique mechanism of action.

Insights

Pharmaceutical Patent Analyst

The grant of a European patent for the combination therapy of Aramchol and Resmetirom by Galmed Pharmaceuticals represents a strategic move to secure the company's intellectual property rights in key markets. This development is particularly noteworthy as it extends the patent protection of Aramchol until 2039, thereby potentially increasing the product's lifecycle and revenue stream for an extended period. The inclusion of major European countries such as France, Germany, Italy, the Netherlands and the United Kingdom underscores the significance of the patent in safeguarding market share in these territories.

From a competitive standpoint, the unique mechanism of action of Aramchol, which targets stearoyl-CoA desaturase-1 (SCD1) in hepatic stellate cells, could differentiate it in a crowded NASH/MASH treatment landscape. This differentiation is important given the high prevalence and unmet medical need in the treatment of liver fibrosis associated with these conditions. The patent not only protects the combination therapy but also may deter competitors from entering the space with similar mechanisms, potentially resulting in a stronger position for Galmed in negotiations with partners or in attracting acquisition interest.

Clinical Research Analyst

The recent patent grant for the combination therapy involving Aramchol and Resmetirom highlights Galmed's commitment to addressing NASH/MASH, diseases with significant unmet medical needs. The Open-Label part of the Phase 3 NASH study showing high rates of fibrosis improvement with Aramchol 300mg BID is encouraging and suggests a promising future for the drug if the results are consistent in the larger, blinded cohort of the study. Such clinical outcomes are key in determining the commercial success of a drug, as they directly influence regulatory approvals and market adoption.

Moreover, the combination therapy approach aligns with current scientific understanding that NASH is a multifactorial disease, often requiring a multi-modal treatment strategy. By targeting different aspects of the disease pathology, the combination of Aramchol and Resmetirom could potentially offer a more comprehensive treatment option, improving patient outcomes and potentially justifying premium pricing strategies upon market entry. The anticipation of patent approval in the United States and other countries could further bolster Galmed's market position, subject to the demonstration of clinical efficacy and safety in ongoing studies.

TEL AVIV, Israel, March 15, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases announced today the grant of a European patent related to the use of a combination of Aramchol and Resmetirom (MGL-3196, REZDIFFRA) for the treatment of NASH/MASH and liver fibrosis. The patent was granted in France, Germany, Italy, the Netherlands and the United Kingdom and the approval of the patent in the United States and other countries is pending. With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until September 2039.

Previously, Galmed reported results from the Open-Label part of its Phase 3 NASH study, which demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with fibrosis improvement. https://galmedpharma.investorroom.com/2022-04-28-Galmed-reports-interim-results-from-the-Open-Label-part-of-the-ARMOR-study-with-Aramchol-showing-robust-fibrosis-improvement-across-multimodality-histological-assessment

Galmed has long believed that the optimum treatment for NASH/MASH will be combination therapy. Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD1) in hepatic stellate cells, resulting in a direct effect on fibrogenesis. Aramchol's unique mechanism of action differs from others in its competitive landscape, positioning it to work as a potent anti-fibrotic compound alongside effective treatments in both approved and pre-approval stages.

Allen Baharaff, CEO and President of Galmed Pharmaceuticals mentioned that "this new patent for the combination of Aramchol and Resmetirom reflects the same spirit of earlier patents which were granted to Galmed by the United States Patent and Trademark

Office (USPTO) for the treatment for hepatic fibrosis." Mr. Baharaff continued "It is clear today that NASH is a chronic condition with multiple liver pathologies. Among all pathologies,

excessive liver fat, high glycemic index and fibrosis are major treatment challenges. By combining Aramchol and Resmetirom, two distinct and selective compounds with complementary mechanisms, we believe this will provide a perfect treatment for NASH."

About Galmed Pharmaceuticals Ltd.

We are a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. We have focused almost exclusively on developing Aramchol for the treatment of NASH and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.

Forward-Looking Statements:

Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believesor anticipate will or may occur in the future.  Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the timing and cost of any pre-clinical or clinical trial, for our product candidates; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol or any other product candidate; our expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH, in patients or any other targeted indication; third-party payor reimbursement for Aramchol or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; our ability to maintain the listing of our ordinary share on The Nasdaq Capital Market; and our expectations regarding licensing, acquisitions and strategic operations. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

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SOURCE Galmed Pharmaceuticals Ltd.

FAQ

What is the significance of the European patent granted to Galmed Pharmaceuticals (GLMD)?

The European patent for the combination of Aramchol and Resmetirom strengthens and extends patent protection for Galmed's lead compound, Aramchol, until September 2039.

What are the key results from Galmed's Phase 3 NASH study related to Aramchol?

Results from the Open-Label part of the Phase 3 NASH study showed that treatment with Aramchol 300mg BID led to a high rate of subjects with fibrosis improvement.

How does Aramchol differ from other anti-fibrotic compounds in the market?

Aramchol down-regulates the expression and activity of SCD1 in hepatic stellate cells, offering a unique mechanism of action for fibrogenesis treatment.

Who mentioned the importance of the new patent for Aramchol and Resmetirom combination therapy?

Allen Baharaff, the CEO and President of Galmed Pharmaceuticals, highlighted the significance of the new patent for the combination therapy.

Why does Galmed believe that combination therapy is the optimal treatment for NASH/MASH?

Galmed believes that combining Aramchol and Resmetirom, two distinct and selective compounds with complementary mechanisms, can address multiple liver pathologies effectively.