DURECT initiates trial for potential metabolic disease drug

DURECT Corporation launched a phase 1 multiple-ascending-dose clinical trial to test DUR-928 for the treatment of various metabolic diseases and acute organ injuries, including nonalcoholic fatty liver disease, nonalcoholic steatohepatitis and acute kidney injury, according to a news release.

In the randomized trial, 20 healthy volunteers will receive DUR-928 once a day for 5 consecutive days, in an effort to evaluate the safety, efficacy and pharmacokinetics of DUR-928, a small-molecule, new chemical entity, according to the release. The patients will be evaluated in two consecutive 10-patient cohorts; the first will receive the drug at a lower dose and the second will receive a higher dose.

“Following the successful completion of our phase 1 oral, single-dose study of DUR-928, we have now begun enrollment for a phase 1 multiple-ascending-dose trial,” James E. Brown, president and chief executive officer of DURECT, said in the release. “This trial will provide valuable information on multi-dose pharmacokinetics that will be important as we continue moving toward phase 2 planned for next year.”

DUR-928 is an endogenous, orally bioavailable small molecule that modulates the activity of several nuclear receptors that play an important regulatory role in lipid homeostasis, inflammation, and cell survival, according to the release. The biological activity of DUR-928 has been demonstrated in various animal disease models, including three representing acute toxic or ischemic organ injury and three representing chronic disorders of hepatic lipid accumulation and dysfunction.