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news.Israel-based Galmed Pharmaceuticals has dosed first patient in its Phase IIa clinical trial of its drug candidate, aramchol, to treat newly formed cholesterol gallstones following bariatric surgery.
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The company is focused on the development and commercialization of a once-daily, oral medication to treat liver diseases and cholesterol gallstones.
The single center, randomized, double blind, placebo controlled Phase IIa trial is being conducted at the Assuta Medical Center in Israel to evaluate the efficacy and safety of a once-daily dose of aramchol for three months in 36 adult patients.
The trial’s primary endpoint is a complete dissolution of newly formed cholesterol gallstones following bariatric surgery.
The secondary endpoints include a decrease of over 50% in the number of newly formed gallstones, prevention of the formation of additional gallstones during the trial period and dissolution of biliary sludge.
The company intends to report top line results from this trial in the first half of 2015.
About 5% of the general population in most countries develops cholesterol gallstones and the current standard of care is surgery, either laparoscopic or open cholecystectomy.