NASH Treatment: Will a Combo Drug Developed by Novartis and Pfizer Make the Cut?

Despite its growing prevalence, there are currently no treatment options for patients with nonalcoholic steatohepatitis (NASH). Now, Novartis and Pfizer and are teaming up in an attempt to change that with a new joint development program for the chronic liver disease.

The agreement between the drugmakers will include a clinical trial involving Novartis’ NASH candidate tropifexor, which will be combined with multiple compounds in development by Pfizer. According to Novartis, these Pfizer-owned compounds will likely include an acetyl CoA-carboxylase inhibitor, a diacylglycerol O-acyltransferase 2 inhibitor and a ketohexokinase inhibitor.

“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.”

Tropifexor is a Farnesoid X receptor (FXR) agonist which could treat several aspects of the NASH disease process, such as steatosis, inflammation and fibrosis. Promising preclinical results from animal studies led the FDA to grant Novartis Fast Track status for tropifexor in 2016.

While the two companies have not released the financial terms of the deal – such as which company will be responsible for development and commercialization costs and how eventual revenue could be shared – Novartis and Pfizer’s combo drug is sure to be a blockbuster if it’s able to demonstrate positive outcomes in patients with NASH.

As a form of non-alcoholic fatty liver disease (NAFLD), NASH affects as much as 6.5 percent of the global population, however patients may exhibit no symptoms of the disease. The accumulation of fat in the liver leads to chronic inflammation and fibrosis, which can eventually lead to cirrhosis if left untreated. Live failure represents the final stage of NASH, which can be fatal.

However, Novartis isn’t putting all its eggs in one basket with tropifexor and its agreement with Pfizer. The Swiss pharma also has pre-existing collaboration and licensing agreements for NASH therapies with Conatus Pharmaceuticals and Allergan.