|DURECT Corporation (NASDAQ:DRRX) Reports robust results from DUR-928 Multi-Dose Phase 1 Study|
|By Marilyn Mullen|
|Monday, 18 May 2015 20:28|
DURECT Corporation (NASDAQ:DRRX) has confirmed receiving positive results from multi-dose Phase 1 clinical trial with oral formulation of DUR-928.DUR-928 is the lead molecule in DURECT's Epigenomic Regulator Program and is a small-molecule, new chemical entity having a broad applicability in metabolic diseases like non-alcoholic fatty liver disease as well as non-alcoholic steatohepatitis.
It is also likely to vital for protection against acute kidney injury along with some other types of acute organ injury.
James E. Brown, President and CEO of DURECT, opined that after the starting successful single-dose Phase 1 study, the firm has got additional safety data which also has no drug accumulation in the multiple-ascending-dose Phase 1 trial. He added that the healthy volunteers did not witness any serious drug-related adverse events and that it plans to conduct Phase 1 trials during second half of the year with injectable administration of DUR-928.
The Phase 1 was a randomized and placebo-controlled multiple-ascending-dose study for assessing safety, tolerability, and pharmacokinetics of DUR-928 when given orally for 5 days to healthy volunteers.
DUR-928 was well-tolerated at both dose levels and patients did witness any significant changes in vital signs, laboratory values or ECG parameters. On the other hand, Peak plasma concentrations achieved were about 100-fold higher than endogenous levels and no accumulation was there in repeat dosing in plasma concentrations.
Shares of the company are reversing early gains and now down 2.55% to $2.29. Earlier in the session, the stock was up as much as 11.50% to $2.59.