Gilead has reported encouraging results in a mid-stage trial of its ASK1 inhibitor selonsertib for non-alcoholic steatohepatitis (NASH), a leading cause of liver disease with no approved therapies.
The phase II trial is looking at selonsertib (GS-4997) on its own or in combination with Gilead’s other NASH candidate simtuzumab – acquired along with Arresto Biosciences for $225m in 2010 – in NASH patients with moderate to severe liver fibrosis.
“The data demonstrate regression in fibrosis that was, in parallel, associated with reductions in other measures of liver injury in patients treated with selonsertib for 24 weeks,” according to Gilead, which presented the data at The Liver Meeting 2016 in Boston this week.
Selonsertib treatment improved several measures of liver disease severity, including fibrosis, progression to cirrhosis, liver stiffness and liver fat content, it added. The combination selonsertib/simtuzumab arm has yet to generate data but is moot as Gilead recently confirmed it is dropping simtuzumab from development.
“Currently, no approved treatments exists for NASH, and patients with advanced fibrosis would potentially benefit from new options to halt and/or reverse the progression of their disease,” commented lead investigator Rohit Loomba of the University of California San Diego School of Medicine.
The positive results are a boost for the US biotech’s ambitions in NASH, an indication for which it has several drugs in clinical development. Analysts have predicted that NASH and other forms of non-alcoholic fatty liver disease (NAFLD) could become a $35bn to $40bn market by 2025.
Along with selonsertib, Gilead is also developing an FXR agonist called GS-9674 in phase I trials and acquired a wholly-owned subsidiary of Nimbus Therapeutics for $1.2bn earlier this year, laying claim to a series of ACC inhibitors for NASH, including phase II candidate NDI-010976.
The company is vying with rivals such as Allergan and Intercept Pharmaceuticals in its pursuit of the NASH market.
Allergan has been building a pipeline of candidates through a series of bolt-on acquisitions including Akarna Therapeutics and Tobira Therapeutics, while Intercept’s home-grown Ocaliva (obeticholic acid) – already approved for primary biliary cholangitis – is also in late-stage trials for NASH.