TEL AVIV, Israel, July 8, 2014 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq:GLMD) ("Galmed") today announced the recent publication of the results of its Phase IIa clinical trial of aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology Journal.
The trial manuscript, entitled "The Fatty Acid–Bile Acid Conjugate Aramchol Reduces Liver Fat Content in Patients with Nonalcoholic Fatty Liver Disease," provides the full report of the Phase IIa trial, which was completed in January 2012 and presented at the 47th Annual Meeting of the European Association for the Study of the Liver in 2012. For the complete manuscript, please visit http://www.galmedpharma.com/for-professionals-2/publications/.
In summary, the Phase IIa trial was a multi-center, randomized, double-blind, placebo-controlled trial of aramchol in 60 Non-alcoholic fatty liver disease, or NAFLD, and Non-Alcoholic Steato-Hepatitis, or NASH, patients in 12 centers in Israel, and its study design was deemed acceptable by the U.S. Food and Drug Administration, or the FDA, in 2007 at a pre-Investigational New Drug scientific advisory meeting. The Phase IIa trial demonstrated that aramchol may reduce liver fat in a dose dependent manner, as evidenced by a statistically significant reduction of liver fat over a three-month treatment period of once-daily 300 mg doses of aramchol, and may induce positive trends of changes in several metabolic parameters. The trial's primary efficacy end point was a reduction in liver fat content, without consideration of inflammation or fibrosis. The secondary efficacy end points measured differences between the aramchol-treated group and the placebo group with respect to alterations of liver enzyme levels, levels of adiponectin, homeostasis model assessment scores, and endothelial function. All endpoints were met and there were no notable changes in biochemical, hematological, cardiovascular or other safety parameters, or any observable serious or drug-related adverse events in the 58 patients who completed the trial either during the three-month treatment period or during the subsequent recovery period. Galmed further confirmed the appropriateness of a single daily dose of aramachol by pharmacokinetic analysis.
Later this year, Galmed intends to begin a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance. This planned Phase IIb clinical trial for aramchol in NASH patients is in accordance with the study design recommended by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, deemed acceptable by Germany's Bundesinstitut fur Arzneimittel und Medizinprodukte, or BfArM, deemed satisfactory by France's Agence Nationale de Securite du Medicament et des Produits de Sante, or ANSM, and confirmed as acceptable by the FDA. BfArM and ANSM also confirmed, in minutes of each of their respective scientific advisory meetings, that if successful, this Phase IIb trial may serve as a basis for Phase III pivotal trials of aramchol.
"We believe that NAFLD and NASH are increasingly relevant public health issues, due in part to their close association with diabetes and obesity, the fact that they are a major causes of cardiovascular and liver-related morbidity and mortality, and their increasing impact on health costs in Western countries where there is a higher prevalence of these diseases," said Allen Baharaff, Galmed's Chief Executive Officer.
About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading "Risk Factors," included in the registration statement on Form F-1 (File No. 333 -193792), initially filed with the Securities and Exchange Commission, or the SEC, on February 6, 2014 and declared effective by the SEC on March 12, 2014, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release reflect Galmed's current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update any forward-looking statements.
SOURCE Galmed Pharmaceuticals Ltd.