Achillion Pharmaceuticals, Inc.announced the presentation of updated results from the ongoing phase 2 ‘604 Study’ being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen). These results were presented as an oral presentation during the European Association for the Study of the Liver (EASL) 2017 International Liver Congress in Amsterdam. These results demonstrate that the triple combination of simeprevir, odalasvir and AL-335 has the ability to shorten treatment duration, offer high efficacy and be generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally.
“The goal of the Janssen HCV development program is to optimize treatment outcomes by providing a novel, simplified therapeutic option with high efficacy, safety, and a shorter treatment duration to address a broad range of patients living with HCV. Importantly, in this study 100% SVR12 was achieved despite the presence of NS5A polymorphisms, which can reduce the efficacy of other HCV regimens, that were observed at baseline," commented David Apelian, M.D., Ph.D., chief medical officer at Achillion. "The clinical community has expressed the need for more simplified treatment options, and these data with JNJ-4178 highlight the potential of this once daily regimen to achieve SVR24 for genotype 1 patients after only six weeks of therapy.”
Study results, presented by principal investigator Dr. Edward Gane, professor of medicine at the University of Auckland and chief hepatologist at Auckland City Hospital, included expanded safety and efficacy data and were made in a presentation entitled "Short duration treatment with AL-335 and odalasvir, with or without simeprevir, in treatment-naïve patients with hepatitis C virus (HCV) genotype 1 infection." It reports that 100% of patients receiving treatment for six or eight weeks with a triple combination of once-daily AL-335 800 mg and simeprevir 75 mg with odalasvir 50 mg every other day achieved a sustained viral response 24 weeks after the completion of treatment (SVR24)
Summary of Phase 2 '604 Study' Design and Interim Results
The oral presentation features clinical trial data examining the safety, pharmacokinetics and efficacy of six and eight weeks of treatment with AL-335 and odalasvir with or without simeprevir to treat HCV in treatment naïve subjects across a range of HCV genotypes and stages of liver disease.
Data from this study demonstrate that JNJ-4178, the three-drug combination of simeprevir, odalasvir and AL-335, was highly effective in treatment naïve patients with HCV genotype 1 infection without cirrhosis, achieving 100% SVR24 for treatment durations of both 6 and 8 weeks. The two-drug regimen of odalasvir and AL-335, a combination regimen not anticipated to move forward, achieved 84% SVR24 for treatment duration of 8 weeks in patients with HCV genotype 1 without cirrhosis. The three-drug regimen of simeprevir, odalasvir and AL-335 in HCV genotype 3 patients without cirrhosis achieved an SVR12 of 77% following 12 weeks of therapy, and is also not anticipated to move forward. Genomic sequencing results indicate that despite the presence of multiple NS5A mutations observed at baseline there was no apparent impact on SVR rates.
