While executives of Durect Corp. plugged “compelling” reduction in mortality from a phase IIb study testing DNMT inhibitor larsucosterol in severe alcohol-associated hepatitis and looked ahead to a potential registrational trial, investors focused on the fact that the study, called Ahfirm, fell short of statistical significance on both primary and secondary endpoints, sending shares (NASDAQ:DRRX) down 79%.
With so many headlines touting drugs in development for the likes of nonalcoholic steatohepatitis and nonalcoholic fatty liver disease, an illness in the same ballpark has been back-seated: alcoholic hepatitis (AH), which is on the rise, under-recognized and brings a one-month mortality rate that averages 26%.
BOSTON In a late-breaking oral presentation on the last day of The Liver Meeting 2019, Durect Corp. reported results from its phase IIa trial of DUR-928 for the treatment of alcoholic hepatitis. All 19 patients enrolled in the study survived for 28 days after treatment with DUR-928 , and all but two responded to the drug as measured by Lille scores, which is used for predicting risk of death.