In an update, Gilead spotlights top-line hits amid a mixed set of PhII data for its $600M NASH drug

Six months after putting out some stellar early-stage data from a study of its NASH drug GS-0976, Gilead has come back with the full slate of results, underscoring the potential here as well as the challenge ahead for researchers.

Rohit Loomba

In the breakdown, investigators pointed to a dose-dependent response on two key measures of the disease, repeating a 43% reduction in liver fat among a small group of patients taking the high dose of the drug, in-licensed from Nimbus for a jaw-dropping $600 million in quick cash.

The full set of scores also highlights a failure for the low, 5 mg dose, as well as a shortfall for a whole range of secondaries, including: liver stiffness by FibroScan, liver stiffness by MRE, serum ALT and PIII-NP, a serum marker of fibrogenesis.

Nevertheless, Gilead remains a staunch advocate of this drug, with big plans to dominate the late-stage field of NASH drugs.

“In patients with advanced fibrosis, NASH may lead to severe complications including end-stage liver disease, hepatocellular carcinoma and the requirement for liver transplantation,” said Rohit Loomba, the lead study author and vice chief of the Division of Gastroenterology at the UC San Diego School of Medicine. “Unfortunately, there are no treatments available for these patients. In this first randomized, placebo-controlled, Phase 2 study of an ACC inhibitor in NASH, the data suggest that GS-0976 has the potential to play an important role in treating patients with this disease.”

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