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Simtuzumab ineffective in phase 2b trials for NASH-related fibrosis

Results of two phase 2b trials showed that simtuzumab was ineffective in reducing fibrosis or hepatic venous pressure gradient among patients with bridging fibrosis or cirrhosis associated with nonalcoholic steatohepatitis.

“The data collected from these large cohorts of well-characterized NASH patients with bridging fibrosis and cirrhosis are an important contribution to the field as the findings will help to inform the design of future clinical trials and improve our understanding of the natural history of NASH,” Stephen A. Harrison, MD, medical director of Pinnacle Clinical Research, San Antonio, and colleagues wrote.

The multi-center studies included one study of 219 patients with bridging fibrosis and one study of 258 patients with compensated cirrhosis. The researchers randomly assigned patients in each group to received 75 mg of simtuzumab (Gilead Sciences), 125 mg of simtuzumab or placebo.

Both studies were terminated before any patients completed the planned 240 weeks of treatment. The researchers assessed a total of 197 patients at 48 weeks and 96 weeks.

At 96 weeks, the treatment groups did not demonstrate a significant change in mean hepatic collagen content compared with the placebo groups at base assessment and after adjusting for diabetes status, weight loss and baseline serum lysyl oxidase like 2 levels.

Similarly, the treatment groups did not demonstrate any significant changes in bridging fibrosis or cirrhosis.

“These data are in keeping with evidence to suggest that patients taking part in clinical trials have better outcomes than matched patients not participating in trials,” Harrison and colleagues wrote. “Future studies are necessary to confirm these observations and quantify factors that may confound the assessment of disease progression in patients with NASH.” – by Talitha Bennett

Disclosure: Harrison reports he serves on advisory committees or review panels for Allergan, Fibrogen and Intercept; consults for Chronic Liver Disease Foundation, Genfit, Madrigal, NGM, Octeta, Perspectum and Pfizer; receives grants or research support from Conatus and Galectin; and receives speaking or teaching fees from Echosens. Please see the full study for the other authors’ relevant financial disclosures.