Pharma, BioPharma

Novartis, Pfizer partner to develop drugs for NASH

The companies will run clinical trials combining Novartis’ tropifexor with any one of several Pfizer drugs under development for the disease, which lacks approved treatments.

Two of the world’s largest drugmakers are working together to investigate treatments for a serious liver disease that has been growing worldwide in tandem with Type 2 diabetes and obesity.

Swiss drugmaker Novartis said Monday that it had inked a deal with New York-based Pfizer to conduct studies of drugs for nonalcoholic steatohepatitis, or NASH, itself an advanced form of nonalcoholic fatty liver disease, known also as NAFLD. Financial terms of the deal were not disclosed.

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The agreement will include a study combining Novartis’s drug tropifexor with one or more Pfizer compounds. The Pfizer drugs under consideration include the acetyl coA-carboxylase inhibitor PF-05221304, the diacylglycerol O-acyltransferase 2 inhibitor PF-06865571 and the ketohexokinase inhibitor PF-06835919. The ClinicalTrials.gov online trial database currently lists four studies of tropifexor, a farnesoid X receptor agonist also known as LJN452. These include two currently recruiting Phase II studies in NASH, a Phase I study in hepatic impairment patients that is also recruiting patients, and a completed Phase II study in primary biliary cholangitis. The Pfizer drugs are also the subject of numerous listed studies, including safety studies in healthy volunteers and trials in patients with liver disease.

NASH, which currently has no approved treatments, has been a growing subject of interest among drugmakers due to its projected growth and significant unmet medical need. An August report by ResearchAndMarkets.com projected that NASH – which can lead to cirrhosis – will become the leading cause of liver transplantation in the coming years. The market, it forecast, is expected to grow from $1.17 billion in 2017 to $21.47 billion by 2025.

Along the way, several companies have plowed resources into developing new treatments. Last week saw the launch of 89Bio, established by OrbiMed with a $60 million Series A financing round from several venture capital firms, with the purpose of developing a pipeline of product candidates from Israeli drugmaker Teva Pharmaceutical Industries. Another company, Glympse Bio, announced earlier this month that it had raised $22 million in Series A funding, also to develop drugs for NASH.

Photo: Nicol??s Mero??o, Getty Images