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.GlobeImmune has reported encouraging 12-week Phase II clinical trial data, which showed that patients treated with GI-5005, the company's targeted molecular immunogen for the treatment of hepatitis C virus infection, had 94% early virologic response rate in treatment naive patients.
Subscribe to our email newsletter
The study compared GI-5005 plus standard of care (SOC) – pegylated interferon and ribavirin – versus SOC alone in patients with chronic genotype 1 hepatitis C virus (HCV) infection.
The 94% early virologic response (EVR) rate in naive subgroups including those with high baseline viral loads, is defined as a greater than 100-fold reduction of HCV RNA from baseline at 12 weeks and is an eight to 12% improvement over the SOC alone arm.
Additional exploratory analyses of serum fibrosis (Fibrotest) and necrosis (Actitest) markers showed a two-fold improvement in the proportion of patients with improved serum Fibrotest, and a 50% reduction in the number of patients with worsening Fibrotest scores after 24 weeks in the group receiving the triple therapy.
At the 24 week time point, the triple therapy improved serum Actitest scores by up to 14% in treatment naive patients when compared to SOC alone. The treatment naive group with high viral load receiving the triple therapy also saw a 14% advantage over the SOC group in normalization of alanine transaminase, a marker of liver damage.
The GI-5005-02 clinical trial is a randomized, multi-center, Phase II study evaluating 140 patients, all with genotype 1 HCV infection. In the trial, 74% of patients had never received prior treatment, and the remaining 26% had failed prior treatment.
David Apelian, chief medical officer of GlobeImmune, said: “At this interim stage of our Phase II program, we are encouraged by the data as we believe they suggest that triple therapy including GI-5005 may improve sustained virologic response as well as liver histology, both of which will be measured in the current study and could serve as primary or co-primary efficacy endpoints in a future Phase III HCV program.”