Biopharma to Accelerate Trial Timeline with Amendment

November 26, 2018

By The Life Science Report

Source: Streetwise Reports   11/21/2018

The change relates to the onset of dosing for patients with different degrees of disease.

DURECT Corp. (DRRX:NASDAQ) announced in a news release it revised its ongoing Phase 2a dose escalation trial of DUR-928 for alcoholic hepatitis (AH), which encompasses two populations: patients with moderate disease (Part A) and patients with severe disease (Part B). The amendment allows DURECT to move up the start of dosing of patients with severe AH.

Now, Part B patients can be enrolled for the first, or lowest, dose (30 mg) at the same time enrollment continues for Part A patients to get the next highest dose (90 mg). (Part A patients, four of them, already received the 30 mg dose.) Three dose levels of DUR-928 (30, 90 and 150 mg), intravenously administered, are planned for testing in Part A patients, and each dose group will contain four to six patients.


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“We expect [the parallel dosing] to accelerate the overall timeline for the trial,” President/CEO James Brown said in the release. “Over the course of the trial, the clinical sites have encountered many severe AH patients who may have qualified for Part B but were deemed screen failures due to their model for end-stage liver disease scores being too high to participate in Part A.”

The study aims to evaluate safety, pharmacokinetic and pharmacodynamic signals and the effect of DUR-928 on liver biochemistry and biomarkers, according to the company.

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