Nonalcoholic Steatohepatitis (NASH)
DUR‑928 is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.
In March 2019 we began enrolling patients in a Phase 1b randomized and open-label clinical study being conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. DUR-928 (at doses of 50 mg QD, 150 mg QD and 300 mg BID) is administered orally for 28 consecutive days with approximately 20 patients per dose group (targeting 15 evaluable per group) for a total of approximately 60 patients in the trial as shown below. Key endpoints include safety and pharmacokinetics (PK), clinical chemistry and biomarkers (e.g., bilirubin, lipids, liver enzymes, CK-18s, and inflammatory cytokines) as well as liver fat content by imaging. In September 2019, we announced that we had enrolled 30 of the planned 60 patients in this trial and expect to complete the trial in the first half of 2020. We plan to announce top line study results following completion of the trial.
NASH Study Schematic
In a previous Phase 1b trial, statistically significant reductions from baseline of several biomarkers were observed in cirrhotic and non‑cirrhotic NASH patients after a single oral dose of 50 mg or 200 mg of DUR‑928. Data from this study were presented at the International Liver Congress™ 2017 in Amsterdam.
Biomarker Changes in NASH Patients After a Single Oral Dose of DUR-928
Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in both children and adults. It is estimated that NAFLD affects approximately 20% to 30% of adults and 10% of children in the United States. Nonalcoholic steatohepatitis (NASH), a more severe and progressive form of NAFLD, is one of the most common chronic liver diseases worldwide, with an estimated prevalence of more than 10% of adults in the United States, Europe, Japan, and other developed countries. No drug is currently approved for treatment of NAFLD or NASH.
DURECT currently holds the worldwide development and commercialization rights to DUR-928 and other molecules identified as part of the Epigenetic Regulator Program.
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.