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-The MHRA agreement follows a similar agreement from the FDA, which allows Galmed to conduct its proposed clinical studies to replace Aramchol free acid with Aramchol meglumine without repeating non-clinical and clinical studies

Tel Aviv, Israel, August 16, 2021/PRNewswire/ - Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or "Company"), a clinical stage liver, metabolic and inflammatory disease The biopharmaceutical company today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has agreed to Galmed’s plan to use Aramchol meglumine instead of Aramchol free acid for its proposed clinical studies without repeating non-clinical and clinical studies. In addition to the planned limited pharmacological studies related to Aramchol meglumine. This follows a similar agreement recently announced by the FDA.

Aramchol meglumine is an improved compound, using the salt form of Aramchol, its water solubility is significantly higher than that of free acid, and the NCE patent protection is valid until December 2034. Aramchol meglumine circulates in the blood as Aramchol.

Allen Baharaff, Co-founder and CEO of Galmed, commented: “Our switch to Aramchol meglumine is part of our overall optimization strategy for the Phase 3 ARMOR study and the MHRA agreement, which was reached after the FDA agreement and represents An important validation of meglumine. The steps we are taking.” Mr. Baharaff continued: “We are fully focused on the open-label part of our Phase 3 ARMOR study and look forward to showing the first third of patients’ experience in the fourth quarter of 2021. result."

About Aramchol and non-alcoholic steatohepatitis (NASH)

Aramchol (arachidonic acid) is a new type of fatty acid bile acid conjugate, liver-targeted SCD1 modulator, developed as an oral therapy for the treatment of non-alcoholic steatohepatitis ("NASH") and fibrosis . The discovery and verification of Aramchol's ability to regulate liver lipid metabolism in animal models proved the three key pathologies of NASH: steatosis, inflammation, and down-regulation of fibrosis. The effect of Aramchol on fibrosis is mediated by the down-regulation of steatosis and directly acts on human collagen-producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

NASH is an emerging world crisis that affects approximately 3% to 5% of the US population, and is estimated to affect 2% to 4% of the global population. Due to the increase in obesity, it is the fastest growing cause of liver cancer and liver transplantation in the United States. NASH is a progressive form of non-alcoholic fatty liver disease that can cause cardiovascular disease, cirrhosis, and liver-related death.

Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol ™, is a backbone drug candidate for the treatment of NASH and fibrosis, and is currently undergoing Phase 3 registration studies. We are also developing Amilo-5MER, a 5-amino acid synthetic peptide, and recently launched the first human study.

This press release may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements related to Galmed's goals, plans, and strategies, as well as statements other than historical facts, which relate to Galmed's intentions, expectations, plans, beliefs, or predictions that will or may occur in the future. These statements are usually expressed in terms such as "believe", "hope", "may", "expect", "should", "intend", "plan", "will", "expect", "estimate", "project", " "Positioning", "strategy" and similar expressions, and based on management's experience and assumptions and assessments made on historical trends, current conditions, expected future development and other factors deemed appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such statements. Many factors may cause Galmed’s actual activities or results to be materially different from the expected activities and results in the forward-looking statements, including but not limited to the following factors: Galmed’s key Phase 3 ARMOR trial or the time and cost of the ARMOR study or any other preclinical Or clinical trials; completion of Aramchol’s ARMOR studies or any other preclinical or clinical trials with good results; the impact of the COVID-19 pandemic; regulatory actions by the FDA or EMA on Aramchol or any other product candidate; Aramchol or any other future product Or the commercial release and future sales of candidate products; Galmed’s ability to comply with all post-market regulatory requirements applicable to Aramchol or any other candidate product in the country/region where it seeks to sell the product; Galmed’s ability to achieve preferential pricing for Aramchol or any other candidate product Capabilities; Galmed’s expectations of the commercial market for NASH patients or any other indications; Aramchol or any other candidate product’s third-party payer reimbursement; Galmed’s estimates of expected capital requirements and Galmed’s additional financing needs; doctors and patients’ expectations of Aramchol or any other Market adoption of other product candidates; the time, cost or other aspects of the commercial release of Aramchol or any other product candidates; the development and approval of Aramchol or any other product candidates for other indications or combination therapy; and Galmed’s license, acquisition, and Expectations of strategic operations. More detailed information about the risks and uncertainties affecting Galmed is contained in the “Risk Factors” under the heading. It may cooperate with the SEC in the future. The forward-looking statements contained in this press release were made on the date of this press release and reflect Galmed’s current views on future events, and Galmed does not undertake and expressly disclaims any obligation to update or revise any forward-looking statements, whether they are Because of new information, future events, or other reasons.

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