Early data shows potential drug for metabolic liver disease well tolerated

In the randomized, multiple-ascending-dose study, 20 healthy volunteers received single doses of DUR-928 daily for 5 days. The patients were divided into two consecutive 10-volunteer cohorts, with the first 10 volunteers receiving DUR-928 at a lower dose and the second at a higher dose, according to the release.

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 DURECT.

“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,” James E. Brown, president and chief executive officer of DURECT, said in the release. “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.”

DUR-928 was well tolerated at both dose levels, with no serious drug-related adverse events being reported, according to the release. There were also significant changes in vital signs, laboratory values or electrocardiogram parameters and none of the volunteers withdrew from the study.

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, DUR-928 was orally bioavailable and safe at all doses tested to date. – by Melinda Stevens

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