Gilead and Intercept draw closer to launch new NASH therapies

The most debated issue at Liver Meeting, organized by AASLD (American Association for Study of Liver Diseases) and underway in San Francisco in these days, are probably therapies for non-alcoholic steatohepatitis. Four companies already have NASH therapies undergoing clinical trials–Intercept Pharmaceuticals, Gilead Sciences, Genfit and Allergan. Three more companies–Madrigal Pharmaceuticals, Viking Therapeutics and Galmed Pharmaceuticals–have investigational drugs currently in Phase II trials. Additionally, Pfizer and Novartis two weeks ago jointly announced they have entered into an agreement to start clinical evaluation of Novartis’ investigational drug tropifexor.

According to experts, Intercept, with obeticholic acid, will be the first company to introduce an efficacious therapy and will significantly capitalize on the opportunity, which is why its shares have risen over 30% over the last few months. Madrigal’s MGL-3196 seems the most efficacious therapy, yet it will take years before being marketed.   Gilead, among all the companies focusing on NASH, probably has the most ambitious plan, with several investigational drugs currently tested.

Importantly, NASH is a widespread condition in the US and Europe, with 15 million patients only in the US. It is caused by sedentary lifestyle and hypercaloric diets. It is now the first cause of kidney transplant, as hepatitis A cases have recently decreased. NASH therapies have created a business currently worth $4.3bn, but expected to reach $26bn before 2026.