Tropifexor safe up to 48 weeks for NASH
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New data showed favorable safety measures up to 48 weeks of treatment with tropifexor in nonalcoholic steatohepatitis, according to a presenter at The Liver Meeting Digital Experience.
“The role of tropifexor as part of a combination therapy indicated for the treatment of fibrotic NASH is also being investigated in ongoing studies,” Arun J. Sanyal, MD, from the Diabetes and Endocrinology Consultant in Morehead City, North Carolina, said during his presentation.
Sanyal presented results from part C of the phase 2 FLIGHT-FXR study.
The investigators randomly assigned 152 patients with fibrotic NASH to receive placebo (n = 51), tropifexor 140 µg (n = 50) or tropifexor 200 µg (n = 51) for 48 weeks. Overall safety and tolerability up to week 52 served as the primary endpoint. Changes in alanine aminotransferase (ALT), aspartate aminotransferase, hepatic fat fraction (HFF), and histological changes such as NASH resolution and fibrosis improvement from baseline to 48 weeks were secondary endpoints.
Patients who completed 48 weeks of treatment included 86% in the patients placebo group, 76% in the tropifexor 140 µg group and 73% in the tropifexor 200 µg group.
Overall rates of adverse events and serious advese events were similar between treatment groups, according to the researchers. Most events were mild and pruritus was the most common adverse event among all groups. Treatment discontinuation rates due to pruritus were low; 0% with placebo, 6% with tropifexor 140 µg and 8% tropifexor 200 µg. There was no evidence of drug-induced liver injury.
However, in both the tropifexor 140 µg and placebo groups, there was one cholecystitis event.
Investigators reported marked reductions in liver enzymes, body weight and HFF with tropifexor vs. placebo.
“A higher proportion of patients in the tropifexor groups achieved a greater than 30% hepatic fat fraction reduction vs. placebo,” Sanyal said. “Dose-dependent decreases in total [NAFLD activity score] and modest improvement resolution without worsening of fibrosis were seen.”
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