Dr. Gilat says the company initially chose to develop Aramchol because of the large potential market size. He reports that 30% of the general population above age 20 has NAFLD. Complications of NAFLD include inflammation, cirrhosis, liver cancer, and cardiovascular disease.
“Gallstones are also devoid of medical therapy at present, though there is surgery. Statins depress body cholesterol synthesis, they do not actively remove cholesterol from the body. We found a statin-Aramchol combination particularly effective. Possibly due to its two natural components, Aramchol has been found to be unusually safe to date,” adds Dr. Gilat.
An international consortium coordinated by Galmed Medical Research has been established for a Phase IIa study of the effectiveness of Aramchol in patients with NAFLD and NASH, and to investigate basic aspects of these diseases. The consortium is composed of six leading liver centers, located in London, Barcelona, Paris, Frankfurt, Prague, and Tel Aviv, as well as five other leading research institutes.
When asked about the advantage Aramchol has over competition in the field, Dr. Gilat replied “The combination of the effects on triglyceride and cholesterol metabolism is, to the best of my knowledge, unmatched by any medicine existing today. Nor is there a single medicine having major beneficial effects on three such frequent and important diseases.”
Moving ahead, the company plans to develop alliances as one of its strategies for success. It is looking to partner with biotechnology and pharmaceutical companies in collaborations that would enhance the growth and market opportunity for both companies. “We hope to be positioned as a key player in the field of treatment of fatty liver diseases, subsequent to demonstration of efficacy in Phase II studies,” says Dr. Angel.
Discussion of licensing and codevelopment opportunities related to Aramchol or development of new or improved drugs based on FABAC technology will also be a focus, as the company continues to build its pipeline and advance existing drugs that can deliver successful therapeutics in the field of liver and cholesterol metabolism to patients. Five to ten years down the road, Dr. Gilat sees the company having licensed or brought to market one to two compounds and developing others.