Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Migenix has received preliminary four-week interim results from a Phase II viral kinetics study in hepatitis C virus treatment-naive patients, which indicate that celgosivir has no negative effects on the tolerability, pharmacokinetics and viral kinetics when combined with the standard of care drugs, pegylated interferon plus ribavirin, as compared to the standard of care drugs alone.
Subscribe to our email newsletter
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.