Pfizer and Novartis to combine tropifexor and one or more Pfizer compounds to treat NASH.

Novartis announced that it has entered into a clinical development agreement with Pfizer which will include a study combining tropifexor and one or more Pfizer compounds for the treatment of NASH, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, and a Ketohexokinase (KHK) Inhibitor (PF-06835919). The financial details of this transaction are not disclosed.

"Novartis has a leading development portfolio in non-viral liver diseases and I believe especially in our combination therapies. Liver diseases, including NASH, are multifaceted with various factors that contribute to the progression of the disease. This makes them difficult to treat with a single compound," said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. "We want to collaborate with multiple partners to drive the science and understanding of how to treat non-viral liver diseases. Targeting different pathways in NASH with a broad array of therapies is an essential strategy to bring the best treatments to patients.

Comment: The condition represents a silent epidemic: a major cause of liver disease worldwide, NASH is now the number one cause of liver transplants for people under 50 in the US. As fat builds up in the liver, it triggers a cycle of chronic inflammation and fibrosis, which, left unchecked, can lead to cirrhosis (scarring) of the liver and the need for a liver transplant. The disease can also raise the risk of liver cancer hepatocellular carcinoma (HCC). A full 12% of the US adult population is thought to have NASH, a figure rising to 70% of patients with diabetes and obesity over 50 years of age. This translates into around 15 million sufferers in the US; five times as many as those with another once-neglected liver disease, hepatitis C. All this means that NASH is tipped to be one of the next big growth areas for pharmaceutical companies, as no drugs currently exist to treat the conditionp.