Enanta Pharmaceutical’s (NASDAQ:ENTA) Phase II ARGON-1 trial investigating its FXR agonist EDP-305 has limited clinical value to demonstrate efficacy in nonalcoholic steatohepatitis (NASH), experts said. In the coprimary endpoint change of alanine aminotransferase (ALT), such levels may not be high enough in all patients to demonstrate impact and level changes could be influenced by many unrelated factors, they said.
Experts were split as to whether the trial should decrease ALT by 50% or reduce ALT levels within the normal range to allow the liver to heal itself. However, one expert noted ALT has more value if measured in a population than in individual patients, and ARGON-1’s 12-week, 125-patient size could be a limitation in showing efficacy potential.
Phase I data showing improved pharmacodynamic markers has limited bearing in predicting ALT success, experts said. Any of EDP-305’s potential clinical advantage in the form of structural difference with other FXR agonists also remains unclear, they added.