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.
Based on its earlier clinical trials, which showed Aramchol to cause a 20% difference in reduction of liver fat content (compared to placebo) after three months of treatment, with no severe adverse effects, Galmed was pre-approved fast-track designation from the US Food and Drug Administration (FDA) and clearance from the British German and French regulatory agencies, which are waiting for results before approving Phase III studies.
Only company targeting early-stage disease
Baharatt explains that NASH affects about 10% of the Western population and is caused mainly by a diet heavy on sugary soft drinks, saturated fats and processed foods. “While there are no approved therapeutics for the treatment of NASH, some drugs are prescribed off-label. However, the efficacy of such drugs has not been proven in well-designed clinical studies, ” and two of them have been banned for use due to severe side effects.
Accordingly, Galmed is one of four companies now doing advanced clinical studies of a novel NASH treatment, each with a different mechanism of action. One of the other drug candidates was recently found to cause an increase in LDL (“bad”) cholesterol in 20% of patients and therefore probably will only be used for those in late stages of the disease.
“I believe we are the only company targeting the pre-fibrotic early stage of NASH, ” Baharaff tells ISRAEL21c.
The Seeking Alpha online platform for investment research calls Aramchol “a prime acquisition candidate” due to its efficacy in clinical trials, safety profile and potential to treat “early stages of the disease, where the patient population is larger. That upstream positioning of Aramchol is a key deal-maker.
Baharaff cofounded the forerunner of Galmed Pharmaceuticals in 2000 with Dr. Tuvia Gilat – a noted Israeli gastroenterologist who passed away in 2011 — based on Gilat’s pharmaceutical research. In its current form, Galmed was incorporated in July 2013 and raised $44 million last year in its initial public offering on the NASDAQ exchange.
The CEO says that the IPO proceeds will keep the 20-employee company running through the 2017 completion of the multicenter study.
Formerly CFO of Galmed, Baharaff holds law and master’s degrees from Cambridge University and the London School of Economics. He previously was senior vice president of Isramex Projects and T+M Trusteeship & Management. He also chairs the committee for educational activities as a board member of the Tel Aviv Museum of Arts.
The company’s chief medical officer, Dr. Maya Halpern, previously served as a medical director for Teva Pharmaceutical Industries, where she was responsible for several clinical trials, including for Azilect, a leading Parkinson’s drug developed by two researchers at the Technion-Israel Institute of Technology. Chaim Hurvitz, formerly a director at Teva, is the company’s chairman of the board of directors. Hurvitz has been involved with other Israeli medical startups including Aposense and Aerodentis.