The interim results include 10 patients who had completed 4-weeks of treatment equally divided between pegylated interferon (alfa-2b) plus ribavirin (PR) and celgosivir 400mg QD plus PR (PRC).
Viral kinetics in both treatment groups are similar with a median reduction in HCV RNA at 4 weeks of 3.5 log(10) versus 3.8 log(10) in the PRC and PR groups, respectively. PRC treatment was well tolerated, with both the PRC and PR groups demonstrating similar tolerability, which is consistent with observations from prior studies. Gastrointestinal tolerability of the PRC treatment was slightly better in this study compared to prior studies. No serious adverse events were reported.
The company will be completing a thorough analysis of the data from this trial, along with data from an extension protocol with patients continuing from a previous Phase II non-responder study to determine the next steps in the development of celgosivir.
Celgosivir, an oral inhibitor of alpha-glucosidase I, is reported to be the only anti-HCV drug in clinical development that acts on host-directed glycosylation.