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FXR candidate for NASH reduces alanine transaminase, liver fat

Enanta Pharmaceuticals announced positive results in alanine aminotransferase and liver fat content reduction from its current trial of EDP-305, a small molecule farnesoid X receptor under investigation for the treatment of nonalcoholic steatohepatitis, according to a press release.

“Based on data from ARGON-1, EDP-305 clearly displays enhanced efficacy over other second-generation FXR agonists currently in development,” Vlad Ratziu, MD, principal investigator from the University Hospitals Pitié Salpêtrière in Paris, France, said in the release. “I look forward to EDP-305’s progress as an important member of the FXR agonist class of drugs.”

Results from the randomized controlled phase 2a study met its primary endpoint of ALT reduction by 28 U/L compared with placebo (P = .049) and reduction in liver fat content by 30% or more in 45% of patients (P < .001).

Treatment with EDP-305 also led to reductions in C4 protein and increases in fibroblast growth factor 19 and alkaline phosphatase.

The investigators noted a consistent safety profile among more than 400 patients who received EDP-305. Pruritus occurred in approximately 51% of patients and led to discontinuation among 1.8% of those treated with 1 mg and 20.8% of those treated with 2.5 mg.

“EDP-305 is differentiated from other FXR agonists in development today by its significant reduction in liver fat at 12 weeks,” Jay R. Luly, PhD, president and CEO of Enanta, said in the release. “Our goal now is to initiate a 72-week phase 2b study named ARGON-2 with histological endpoints in NASH patients, which we plan to initiate in the first half of calendar 2020.”

Reference: www.enanta.com