Sydney, Australia-based Benitec Biopharma has announced it will terminate its hepatitis C program because the company has concluded TT-034 is no longer commercially viable to bring to market. But the program won’t be discontinued until all patients complete their treatment in Cohort 4 of the Phase 1/2a clinical trial for TT-034.
The biopharma’s board of directors decided to discontinue the program after a review of the commercial opportunities for TT-034, as a number of effective therapies have become available for hepatitis C since the launch of the trial in January 2014. Several other companies have recently improved their therapies’ efficacy, delivery, and success rates, with lower prices and reduced treatment periods.
Board members concluded the hepatitis C program does not hold enough commercial value to attract worthwhile partnership deals and will suspend the trial after completion of patients in the fourth cohort. Benitec said the results of the trial will provide valuable data to support and validate the company’s ddRNAi technology platform and other programs in the company’s pipeline.
Benitec has committed to complete the collection of trial data and monitor patients throughout the pre-established long-term safety follow-up period, and data on primary and secondary endpoints will be reported in the fourth quarter of 2016, when the study is concluded.
Despite the program’s discontinuation, TT-034 was shown safe and well tolerated by patients, meeting the primary study’s endpoint and so it is suitable for assistance in future programs and trials.
“The TT-034 hepatitis C program is a First-in-Man trial. The data presented to date shows that TT-034 transduces hepatic tissues, expresses the anti-hepatitis C shRNA and has a favorable safety profile with no significant adverse events reported relating to the administration of the study drug,” Benitec Chief Scientific Officer David Suhy said in a press release.
“Considering the novel characteristics of the drug, administered in a manner that cannot be withdrawn, we are pleased with the validity that TT-034 has shown in this trial. It has provided solid proof of concept for our ddRNAi platform and our other pipeline programs, particularly our hepatitis B program,” he said.
Benitec will continue to dedicate efforts to other pipeline programs, including hepatitis B; age-related macular degeneration (AMD); and oculopharyngeal muscular dystrophy (OPMD). The hepatitis B program will particularly interest other pharmaceutical companies which might attract beneficial partnerships for drug development and commercialization. Based on this potential interest, and pior in vivo data, Benitec will priotitize the hepatitis B program as next in line for clinical development.
An archive of the webcast where the company presented this information is available for the next three months.