DURECT Corporation Announces DUR-928 Granted FDA Fast Track Designation for Treatment of Alcoholic Hepatitis

IndustryPRwire -- DURECT Corporation 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.  

Norman L. Sussman, M.D., Chief Medical Officer of DURECT Corporation Commented "Fast Track Designation highlights the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, As an endogenous epigenetic regulator, DUR-928 is a new class of therapeutics. We are very encouraged by the promising clinical data from 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.

About Alcoholic Hepatitis (AH)

AH is an acute form of alcohol-associated liver disease (ALD) that may occur after months or years of excess alcohol consumption, often after a recent period of intense consumption.   AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient.

About DUR-928

DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.

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