Hepion Pharmaceuticals (NASDAQ:HEPA) has dosed the first hepatitis B virus (HBV) patient in a 28-day multiple ascending dose clinical trial of CRV431.
The trial will assess the safety, tolerability and pharmacokinetics of CRV431 in four cohorts of HBV patients, who will receive CRV431 in doses ranging from 75 mg to 375 mg in combination with 300 mg tenofovir disoproxil fumarate (TDF), an antiviral, over a 28-day period.
The study is the third and final stage of Hepion’s early clinical program for CRV431 that was agreed upon with the FDA.
“Having established safety and tolerability of CRV431 alone, as well as when co-dosed with TDF, this trial will monitor safety, tolerability and pharmacokinetics of CRV431 when administered repeatedly for 28 days in virally-suppressed HBV patients,” Dr. Robert Foster, Hepion’s CEO said in a statement.
A fifth dosing cohort will measure CRV431’s effect on inflammation and fibrosis. Patients in this cohort will receive 225 mg CRV431 so exploratory markers of HBV infection and liver fibrosis may be analyzed.
“Although the study’s focus will be on markers of safety, we will also look for any anti-viral and anti-fibrotic activity,” Dr. Foster added.
Dr. Stephen Harrison, medical director of Pinnacle Clinical Research and a visiting professor of hepatology at University of Oxford’s Radcliffe Department of Medicine, said, “CRV431 is a promising candidate for HBV patients who still need therapies in the absence of a cure. As a new class of drug for liver disease with a novel mechanism of action, CRV431 has the potential to decrease viral markers and fibrosis.”