DUR-928 is the lead product candidate in DURECT’s Epigenetic Regulator program. It is an endogenous, orally bioavailable small molecule that has been shown in nonclinical studies to modulate the activity of nuclear receptors playing an important regulatory role in cellular functions such as lipid homeostasis, inflammation, and cell survival.
DUR-928 is a sulfated oxysterol—representing a new class of therapeutics with a novel mechanism of action. DUR-928 epigenetically modifies gene activity without changing the DNA sequence itself.
Over 200 individuals have been dosed with DUR-928 by oral (PO), intramuscular (IM), or intravascular (IV) administration in a series of Phase 1 clinical trials. DUR-928 was well tolerated at all doses. There was minimal food effect in the oral administration studies and no accumulation with repeat dosing in any of these studies.
DURECT has announced positive results from a Phase 2a clinical trial of DUR-928 in alcoholic hepatitis (AH) by the IV route, and topline data from a nonalcoholic steatohepatitis (NASH) Phase 1b trial, in which DUR-928 improved important serum liver enzymes, liver imaging and serum lipid profile in only 28 days.
DUR-928 is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.
There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.