The peer-reviewed journal, Clinical Pharmacology in Drug Development, published the results of a clinical trial examining the effect of food on the oral bioavailability of Hepion Pharmaceuticals’ (NASDAQ:HEPA) lead drug candidate, rencofilstat.
The article reviews a Phase 1, randomized, open-label trial in healthy subjects, which assessed the bioavailability of a single dose of rencofilstat in both fasted and high-fat conditions.
“This study showed that taking rencofilstat with a high fat meal increases the absorption of this cyclophilin inhibitor and confirms the safety of the drug while providing the flexibility for patients to take rencofilstat with or without food,” Patrick Mayo, Ph.D., senior VP of clinical pharmacology and analytics for Hepion, said in a statement.
“The increased absorption did not cause toxicity, and it is possible the increased exposure with food could enhance rencofilstat’s efficacy in those non-alcoholic steatohepatitis (NASH) and/or hepatocellular carcinoma patients who may be poor absorbers of the drug,” he added.
Todd Hobbs, M.D. and CMO of Hepion, said that in previous and ongoing clinical trials using rencofilstat, subjects take their daily dose either fasting or with a small, low-fat meal.
“The results from this well-controlled food effect study demonstrate that we can be comfortable with administration of rencofilstat under real-world, everyday conditions with or without a meal,” Dr. Hobbs said.
The article may be accessed here.
