DURECT Corp. (DRRX:NASDAQ) announced in a news release that enrollment began for its Phase 1b nonalcoholic steatohepatitis (NASH) trial.
This is a multicenter, open-label study will evaluate the company's lead drug, DUR-928, in patients with NASH, a complex, chronic liver disease. Three doses—low, middle and high—of DUR-928 will be assessed for safety, pharmacokinetics and signs of biological activity.
A total of 60 patients will be enrolled, 20 per dose. Each patient will receive their assigned dose of DUR-928 for 28 consecutive days. DURECT plans to release initial study data in H2/19.
"[With] this endogenous molecule with a novel mechanism of action, it will be intriguing to see what biological signals are generated in this multidose study, especially given what was previously reported in the single-dose study," Dr. Brent Tetri, professor of internal medicine at Saint Louis University, said in the release.
Tetri will deliver a talk on NASH and answer questions during a conference call hosted by DURECT at 11 a.m. EST on Wednesday, April 17. The company will also discuss its development plan for DUR-928 on the call.
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