DURECT Corp. Reports Positive Results from DUR-928 Multi-Dose Ph

DURECT Corporation (Nasdaq: DRRX) today 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 (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). It may also play an important role in protecting against acute kidney injury (AKI) and other types of acute organ injury. "Following our initial successful single-dose Phase 1 study with orally administered DUR-928, we now have generated additional safety data, including no drug accumulation in this multiple-ascending-dose Phase 1 trial and once again the healthy volunteers experienced no severe or serious drug-related adverse events," said James E. Brown, President and CEO of DURECT. "As we continue to progress with oral administration trials of DUR-928, we also plan to conduct Phase 1 trials during the second half of this year with injectable administration of DUR-928."Description of Phase I Multiple-Ascending-Dose Study with DUR-928 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.