Tarek I Hassanein, MD, an expert hepatologist and clinical investigator, presents for DURECT Corporation as Key Opinion Leader or “KOL” on the results of a Phase 2a clinical trial of DUR-928 in patients with alcoholic hepatitis (AH). Consider attending the Liver Meeting® 2019 at 8:30AM EST on Tuesday, November 12, 2019.
The Problem: What is Alcoholic Hepatitis (AH)?
The Mayo Clinic reports that AH is inflammation of the liver caused by drinking alcohol. It is most likely to strike in those who drink heavily over many years. However, not all drinkers develop alcoholic hepatitis and the disease can occur in people who only drink moderately. It can lead to more problematic conditions such as liver failure.
What is DUR-928?
An investigational product (not approved by the FDA), DUR-928 is the lead product candidate in DURECT’s Epigenetic Regulatory 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.
What is it Considered a New Class of Therapeutic?
DURECT positions that because it is a sulfated oxysterol it hence represents a new class of therapeutic with a novel mechanism of action. DUR-928 epigenetically modifies gene activity without changing the DNA sequence itself.
What is the Track Record in Clinical Trials?
The biotech venture is presently conducting clinical trials of DUR-928 in alcohol hepatitis (AH) by the IV route, nonalcoholic steatohepatitis (NASH) by the PO route, and psoriasis by topical administration.
Over 150 individuals have been dosed with DUR-928 by oral (PO), intramuscular (IM), or intravascular (IV) administration in a series of Phase I clinical trials. DUR-928 thus far has been well tolerated at all doses reports DURECT. There has been minimal food effect in the oral administration studies and no accumulation with repeat dosing in any of these studies.
Who is Dr. Tarek I Hassanein, MD?
Dr. Hassanein, a board-certified gastroenterologist and transplant hepatologist who specializes in liver disease, focuses on the management of viral hepatitis, fatty liver disease, cirrhosis and care of patients before and after liver transplantation. Educated in Egypt, he completed residence in internal medicine at Wayne State University in Detroit. He completed research and clinical fellowship in gastroenterology, hepatology and transplantation at the University of Pittsburgh. He is a fellow of the American College of Physicians, American College of Gastroenterology, and the American Gastroenterological Association.
Do you want to Hear Dr. Hassanein?
Dial-In and Webcast Information
Tuesday, November 12 at 12 noon EST
Domestic (Free): 1-877-407-0784
Toll / International: 1-201-689-8560
Conference ID: 13696593
Webcast with slides