Efruxifermin safe, well-tolerated in patients with NASH with advanced fibrosis
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Among patients with FIB-4 nonalcoholic steatohepatitis at greater risk for progression to end stage liver disease, researchers at the International Liver Congress found efruxifermin 50 mg was safe and well-tolerated.
“Consistent with the Balanced Main study, [efruxifermin (EFX)] treatment appeared to improve liver histology,” Stephen Harrison, MD, medical director, Pinnacle Clinical Research, The University of Texas, visiting professor of hepatology at the University of Oxford, said during his presentation.
“The observed reductions in noninvasive markers of liver injury and fibrosis were consistent with inhibition of fibrogenesis. The improvements in overall metabolic health point to sustained reduction in proinflammatory signaling.”
Harrison and colleagues randomly assigned 30 NASH patients with FIB-4 fibrosis to receive once-weekly EFX 50 mg (n = 20) or placebo (n = 10) for 16weeks. Safety and tolerability of EFX in patients with FIB-4 at the greatest risk for progressing to end stage liver disease was assessed. Other endpoints evaluated included non-invasive markers of fibrosis and markers of glucose and lipid metabolism; an exploratory end point evaluated changes in liver histology in a subset of patients who consented to optional biopsies.
Results showed tolerability with EFX 50 mg in NASH patients with FIB-4 fibrosis was similar to that of patients with FIB1 to FIB-3 fibrosis. Harrison and colleagues said after 16 weeks EFX improved markers of fibrosis, liver injury and glucose and lipid metabolism.
“[Clinically] meaningful and statistically significant improvements in serum lipo-protein profiles are evident following 16 weeks of treatment with EFX,” Harrison said.
Investigators reported of the 12 patients treated with EFX in the liver biopsy analysis set confirmed to be FIB-4 fibrosis at baseline, four achieved improvement in fibrosis or reversal of cirrhosis without worsening of NASH and three achieved resolution of NASH.
Harrison and colleagues noted no patients in the placebo liver biopsy analysis set achieved any of the histologic endpoints.
“Approximately half of [FIB-4] NASH patients have type 2 diabetes,” he said. “Generally, their type 2 diabetes is not well controlled so improving their glycemic control is highly desirable. [EFX] solicited clinically meaningful and statistically significant improvements in multiple markers of glycemic control on top of their existing antidiabetic medications which we believe can be attributed to insulin sensitization.”
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Harrison, et al. Abstract: LBO-2800. Presented at: The International Liver Congress; June 23-26 (virtual meeting).
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