Galmed Pharmaceuticals in Israel is developing a medication to treat NASH, a severe form of fatter liver disease affecting 10 percent of the Western population.
Non-alcoholic fatty liver disease is reportedly the most common liver condition in the developed world, affecting about 30 percent of that population. The only cure is dietary modifications and exercise, or at least regular resistance training, as a recent Israeli study found.
However, because few patients are willing or able to make radical lifestyle changes, several pharmaceutical companies are working to develop medical treatments for this growing problem estimated to carry a $76 billion healthcare price tag in the United States and Europe.
One of the most advanced pilot drugs under development is by Galmed Pharmaceuticals, headquartered in Tel Aviv and New York. Galmed’s metabolic drug candidate Aramchol is formulated to treat non-alcoholic steato-hepatitis (NASH), a severe form of fatty liver disease associated with increased risk of liver cirrhosis, liver failure, hepatocellular cancer and metabolic and cardiovascular diseases.
“We are currently advancing toward our Phase IIb study — the most complex and one of the largest studies for this disease – involving 240 NASH patients in nine countries at 75 centers in Europe, the United States and Latin America,” says Galmed president and CEO Allen Baharaff. “This is important because it will be the first study that will have data from many different populations.”
Each participant will have a liver biopsy at baseline and another after 52 weeks of oral treatment with Aramchol, along with a three-month follow-up exam.