DURECT initiates clinical trial of DUR-928 for NASH

DURECT Corporation announced it has initiated its single-ascending-dose phase 1b clinical trial of DUR-928 for the treatment of nonalcoholic steatohepatitis.

The trial is a single-ascending-dose safety and pharmacokinetic study of DUR-928, an endogenous, small-molecule new chemical entity, in 30 patients with NASH and comparing them with 18 controls. It will be conducted in three successive cohorts evaluating three single-dose levels of oral DUR-928, according to a press release.

“We are excited to have the DUR-928 chronic metabolic disease program advance into patient studies,” James E. Brown, president and CEO of DURECT, said in the release. “DUR-928 has demonstrated no adverse events in our previous studies with healthy volunteers. Gathering data from NASH patients in this trial will position the program for subsequent clinical studies.”

In a previous press release, DURECT reported positive results from a phase 1 injectable study of DUR-928 conducted in 2015.

In the study, healthy volunteers were randomly assigned to receive DUR-928 at escalating doses (n = 16) or placebo (n = 8). DUR-928 was well-tolerated at all dose levels, with no treatment-related adverse events reported, according to the release.

“During 2015, more than 75 healthy volunteers received DUR-928 given either orally or through injection at varying doses in excess of endogenous levels, with no treatment related adverse events reported,” Brown said in the previous release. “Building on our learnings from [eight] animal models that were previously reported, we now look forward to beginning patient studies in our chronic metabolic and acute use programs in 2016.”

The study is currently being conducted in Australia and should be completed in the first half of 2016, according to DURECT.

Disclosure: Brown is employed by DURECT Corporation.