Fourth patient dosed with 'one-shot' drug in HCV trial

A fourth patient in the phase 1/2a clinical trial of TT-034, a ddRNAi-based therapeutic to treat hepatitis C virus infection, has been dosed with the highest amount of concentration of the drug in trials so far, according to a news release from Benitec Biopharma Limited.

The phase 1/2 clinical trial being conducted at the Duke Clinical Research Unit of Duke Clinical Research Institute is an open-label dose escalation study that evaluates the safety and activity of single doses of TT-034 (Benitec), a potential treatment for HCV with a single-dose administration, in patients with chronic HCV genotype 1 infection who have failed previous treatments, according to the Duke Clinical Research Unit website. The trial consists of 14 patients in five sequential dose cohorts.

The fourth patient is the second patient to be dosed in cohort two, with the third and final patient in the cohort two to be well advanced in their preparation for dosing, according to the release.

Patients in cohort two received an increased dose of TT-034 that was a half-log higher than patients dosed in the first cohort, according to the release. The Duke Clinical Research Unit will monitor the current patient for 6 weeks and submit results to the Data Safety Monitoring Board (DSMB) for proper review. After review, the DSMB plans to determine whether to recommend the two remaining patients enrolled in the trial be included in the final dosing cohort.

No significant adverse events related to treatment were reported from the previous cohort, according to a previous release.