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HCV Trial of ‘One-Shot’ Drug Continues
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A third 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 cure 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 5 sequential dose cohorts.
The current cohort 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 would 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 the release.