Galmed Pharmaceuticals : Results of Galmed’s Phase 2b ARREST Trial of Aramchol Published in Nature Medicine – Form 6-K

Results from Galmed’s Phase 2b ARREST study with aramchol published in Nature Medicine

– The data complements the growing body of clinical and scientific evidence demonstrating the therapeutic potential of aramchol, a stearoyl-CoA desaturase (SCD 1) down regulator, for the treatment of NASH and fibrosis

– A Phase 3 program is currently underway with a higher daily dose of aramchol

TEL AVIV, Israel, Oct. 11, 2021 / PRNewswire / – Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company in liver, metabolic and inflammatory diseases, today announced that the annual results of the global, randomized, placebo-controlled Phase 2b ARREST Studies of aramchol in patients with NASH were published in Nature Medicine (https://www.nature.com/articles/s41591-021-01495-3).

In the Phase 2b ARREST study, 247 patients with NASH were randomized and confirmed by a liver biopsy. Patients were randomized in a 2: 2: 1 ratio to receive aramchol 400 mg, 600 mg, or placebo once daily. The manuscript describes the complete data analyzes including liver fat reduction through imaging, improvements in liver histology and liver enzymes, and aramchol’s very good safety profile.

Aramchol is the most advanced down regulator of SCD 1 in clinical development. Aramchol, by targeting this single receptor, a major metabolic master switch, induces a cascade of events leading to two main changes: In hepatocytes, aramchol increases fatty acid oxidation (or in other words – fat burning) and affects AMPK, which also results in it in reducing glycemic parameters; and in hepatic stellate cells, aramchol regulates collagen production (i.e., fibrosis). The data from the Phase 2b ARREST study published in this article demonstrate how aramchol’s mechanism of action translates into clinical performance.

This published study, in addition to the previously demonstrated and published mechanistic studies, provided the rationale for further development of aramchol for patients with NASH and fibrosis and the potential for further improvement in efficacy through higher drug exposure (> 50% higher).

The ARMOR Study – a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial to evaluate the efficacy and safety of Aramchol 300 mg twice daily in patients with NASH with an open section to evaluate safety, PK and kinetics Response to treatment for aramchol is currently ongoing (NCT04104321).

Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université, lead author of the study and co-director of the ARMOR study, commented: “The publication of the detailed results of the ARREST study in a prestigious general medical journal such as Nature Medicine is appealing. ” pointed out to the scientific community this molecule with an innovative mechanism of action and its potential for treating fibrotic NASH. We look forward to seeing the effects of optimized aramchol exposure in NASH patients from the Phase 3 ARMOR study. ”

“The publication of these data in Nature Medicine demonstrates the strong clinical community interest in this unmet need. We are grateful to all of the patients and clinical centers around the world who participated in the study, ”said Allen Baharaff, President and CEO of Galmed. “Coupled with recent recent publications shedding light on aramchol’s MoA and, in particular, its direct effects on fibrosis, these results underscore the significant potential of aramchol as a therapeutic option for patients diagnosed with NASH and fibrosis. We are committed to evaluating the safety and efficacy of aramchol in patients diagnosed with NASH and fibrosis in our ongoing ARMOR Phase 3 study. ”

About aramchol and non-alcoholic steatohepatitis (NASH)

Aramchol (arachidylamidocholanic acid) is a novel fatty acid-bile acid conjugate, a liver-targeted SCD1 modulator that was developed as an oral therapy for the treatment of non-alcoholic steatohepatitis (“NASH”) and fibrosis. Aramchol’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating the downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. Aramchol’s effect on fibrosis is mediated by downregulating steatosis and directly on human collagen-producing cells. Aramchol has received Fast Track Designation status from the FDA for the treatment of NASH.

NASH is an emerging world crisis that affects an estimated 3 to 5% of the US population and an estimated 2 to 4% worldwide. It is the fastest growing cause of liver cancer and liver transplants in the US due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver, which can lead to cardiovascular disease, liver cirrhosis, and liver-related mortality. There are currently no approved therapies for NASH.

Galmed Pharma Ltd.

Galmed Pharmaceuticals Ltd. is a biopharmaceutical company engaged in the clinical development of drugs for liver, metabolic and inflammatory diseases. Our lead compound Aramchol ™, a backbone drug candidate for the treatment of NASH and fibrosis, is currently in a Phase 3 registration trial. We are also working with the Hebrew University on the development of Amilo-5MER, a synthetic 5 amino acid peptide.

Forward-looking statements:

This press release may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed’s goals, plans and strategies, as well as statements other than historical fact that relate to activities, events or developments that Galmed intends, expects, projects, believes or is expected to do, or in which Future can come. These statements are often accompanied by terms such as “believes”, “hopes”, “can”, “anticipates”, “should”, “intends”, “plans”, “will”, “expects”, “estimates”, “projects” , “positions”, “strategy” and similar expressions and are based on assumptions and estimates made in the light of management’s experience and perceptions of historical trends, current conditions, expected future developments and other factors deemed appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmed’s actual activities or results to differ materially from those anticipated in any forward-looking statement, including, but not limited to: the timing and cost of Galmed’s pivotal ARMOR trial or the ARMOR- Study or other preclinical or clinical studies; Completion and receipt of positive results from the ARMOR study for Aramchol or any other preclinical or clinical study; the impact of the COVID-19 pandemic; regulatory action in relation to aramchol or any other product candidate by the FDA or EMA; the commercial launch and future sales of Aramchol or other future products or product candidates; Galmed’s ability to meet all applicable post-market regulatory requirements for Aramchol or other product candidates in the countries in which the product is intended to be marketed; Galmed’s ability to fetch affordable prices for aramchol or other product candidates; Galmed’s expectations for the NASH patient commercial market or other indications; Third party reimbursement for Aramchol or any other candidate product; Galmed’s estimates of expected capital requirements and Galmed’s need for additional funding; Market acceptance of Aramchol or another product candidate by doctors and patients; the timing, cost, or other aspect of the commercial launch of Aramchol or any other candidate product; the development and approval of the use of aramchol or another product candidate for additional indications or in combination therapies; and Galmed’s expectations for licenses, acquisitions, and strategic operations. More detailed information about the risks and uncertainties affecting Galmed can be found under the heading “Risk Factors” in Galmed’s latest Annual Report on Form 20-F, filed with the SEC on March 18, 2021, and in other Galmed filings with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed’s current views with respect to future events, and Galmed assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or for other reasons.

Investor contact: Guy Nehemya, Chief Operating Officer, Galmed Pharmaceuticals Ltd.,

investor.relations@galmedpharma.com, + 972-3-693-8448

Disclaimer of liability

Galmed Pharma Ltd. published this content on October 12, 2021 and is solely responsible for the information contained therein. Distributed by public, unedited and unchanged, on October 12, 2021 11:11:14 AM UTC.