NEW YORK (GenomeWeb) – Benitec Biopharma last week disclosed delays in its efforts to dose patients in a Phase I/IIa trial of its expressed RNAi-based hepatitis C treatment TT-034 and said that it is taking steps to speed subject enrollment.
TT-034 is designed to express shRNAs targeting three portions of the HCV genome and was administered to the first patient in the planned 14-patient trial in June. However, Benitec said this week that dosing additional patients in that study is taking longer than anticipated due to the failure of two patients to meet trial inclusion criteria.
During a 28-day monitoring process, the company said, these patients experienced fluctuations in viral load and/or liver enzymes that were beyond the acceptable limits of the Phase I/IIa trial. Currently, additional patients are going through the monitoring process, and the first to satisfy the study criteria will be dosed.
At the same time, Benitec said it is working to accelerate patient enrollment by adding clinical trial sites to the TT-034 program, reviewing the study's enrollment process to "identify areas of enhancement," and appointing a clinical trial specialist to "actively manage" the study in collaboration with the contract research organization managing it.