Benzinga | Dec 16, 2020 08:31AM EST

DURECT Corporation Announces DUR-928 Granted FDA Fast Track Designation For Treatment Of Alcoholic Hepatitis

CUPERTINO, Calif., Dec. 16, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DUR-928 for the treatment of alcoholic hepatitis (AH, also known as alcohol-associated hepatitis). AH is an acute, life-threatening form of alcohol-associated liver disease (ALD). DUR-928 is the lead investigational product candidate in DURECT's Epigenetic Regulator program.

"Fast Track Designation highlights the life-threatening nature of AH and the lack of therapeutic options for this devastating condition," said Norman L. Sussman, M.D., Chief Medical Officer of DURECT Corporation. "As an endogenous epigenetic regulator, DUR-928 is a new class of therapeutics. We are very encouraged by the promising clinical datafrom our Phase 2a trial in which 100% of AH patients treated with DUR-928 survived the 28-day follow-up period compared to a 26% historical 28-day death rate. We look forward to initiating our Phase 2b trial shortly and working with the FDA to bring DUR-928 to the many patients in need as soon as possible."

The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track Designation can benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.