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News Breaks
February 13, 2014
07:55 EDTDRRX, DRRXDURECT to host conference call
Conference call to discuss response letter from FDA for POSIDUR will be held on February 13 at 8:30 am. Webcast Link
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May 18, 2015
08:31 EDTDRRXDURECT announces positive results from DUR-928 Phase 1 study
DURECT announced that it has obtained positive results from a multi-dose Phase 1 clinical trial with an oral formulation of DUR-928, the lead molecule in DURECT's Epigenomic Regulator Program. DUR-928 is an endogenous, small-molecule, new chemical entity, which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. It may also play an important role in protecting against acute kidney injury and other types of acute organ injury. This Phase 1 trial was a single-site, randomized, double-blinded, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of DUR-928 when orally administered once daily for 5 consecutive days to healthy volunteers. The 20-subject study evaluated DUR-928 in 2 consecutive 10-subject cohorts, the first receiving DUR-928 at a lower dose and the second at a higher dose. Following multiple dosing, DUR-928 was well-tolerated at both dose levels, with no clinically significant changes in vital signs, laboratory values or ECG parameters, no severe or serious drug-related adverse events reported and no subjects withdrawing from the study. Peak plasma concentrations achieved were at least 100-fold higher than endogenous levels, no accumulation in plasma concentrations were observed with repeat dosing, and dose related increases in plasma concentrations were observed with peak plasma concentration at approximately 2 6 hours after dosing.

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