As late-stage NASH readouts of Intercept $ICPT, Gilead $GILD and France’s Genfit (Euronext: GNFT) loom, Pfizer $PFE on Monday announced plans to tackle the so far untreated fatty liver disease with Novartis $NVS for a piece of the multibillion dollar market that has long generated feverish interest from small and big drugmakers alike.
NASH is characterized by a buildup of excess fat in the liver that induces chronic inflammation and eventually culminates in scarring that can lead to cirrhosis, liver failure, cancer and death. The disease, which is typically associated with obesity and diabetes, is set to eclipse hepatitis C as the leading reason for liver transplants by 2020. Dubbed the silent disease, it is hard to diagnose in the early stages, making it difficult to estimate its prevalence, but studies show that it afflicts up to 12% of the adult population in developed countries. Although there are no approved drugs for the disease, the size of the NASH market is expected to cross $20 billion by 2025.
Novartis is set to test its experimental FXR agonist tropifexor in combination with a trifecta of Pfizer drugs in different stages of development.
Tropifexor, which is also being evaluated in combination with a NASH drug from Allergan $AGN, has secured the FDA’s fast track designation. Like Intercept’s FXR agonist Ocaliva, tropifexor is designed to activate FXR, a nuclear hormone receptor regulated by bile acids that is believed to be an effective approach in the fight against the liver disease not caused by heavy alcohol abuse.
— Bruce Booth (@LifeSciVC) October 29, 2018
Data from a Phase III trial testing Ocaliva are expected next year, along with results from other late-stage offerings — Gilead’s ASK1 inhibitor selonsertib and Genfit’s elafibranor.
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