Boehringer Ingelheim today announced the completion of patient enrolment for a Phase IIa clinical trial investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. The trial is conducted in collaboration with Presidio Pharmaceuticals, Inc. and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir and non-nucleoside NS5B polymerase inhibitor, deleobuvir, in combination with Presidio’s pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.
The trial includes 36 treatment-naïve genotype-1a infected patients treated for 12 weeks with this all-oral DAA regimen, with 24 weeks of post-treatment follow-up. The primary endpoint of the trial is sustained virologic response 12 weeks after treatment is completed (SVR12). This Phase IIa trial of a novel combination therapy is part of Boehringer Ingelheim’s commitment to develop new, tailored interferon and potentially ribavirin-free HCV regimens for a broad range of HCV patients.
In March 2013, the two companies entered a non-exclusive collaboration to evaluate the three DAAs in combination regimens. Both companies will retain all rights to their respective compounds. Presidio has operational responsibility for this collaborative trial, with oversight by an intercompany project team. Final results are expected in Q2 2014.
“We are pleased to announce that enrolment is complete in this collaborative Phase IIa trial evaluating a new 12-week interferon-free treatment regimen. This regimen complements and expands our HCV portfolio with the goal of providing interferon-free treatments to patients with HCV,“ said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. ”This study is the next step in our continued commitment to deliver effective and well-tolerated treatment options that are optimised for patients with different hepatitis C genotypes. The pan-genotypic properties of PPI-668 bear the potential to explore the efficacy of this regimen in a wider range of HCV genotypes in the future.”
Eliminating injectable interferon from treatment is a critical goal in hepatitis C management. Clinical studies have shown that up to 50 percent of patients may not be eligible for treatment with interferon due to contraindications. Patients may also find interferon challenging due to the long treatment duration and side-effects. These side-effects commonly include fatigue, anxiety, depression, gastrointestinal and flu-like symptoms as well as more serious side-effects such as heart failure, sepsis, leukopenia, depression and vision loss.
“Clinical trials evaluating multiple DAAs are exciting because they can help bring us closer to our goal of developing more effective and tolerable interferon-free and potentially ribavirin-free therapies,” said Jacob Lalezari M.D., Director of Quest Clinical Research in San Francisco, CA. ”By treating patients with multiple compounds that attack the hepatitis C virus in different ways, we hope to be able to cure more patients in less time with fewer of the side-effects associated with existing treatment options.”
Boehringer Ingelheim has a comprehensive interferon-free clinical trial programme which includes three pivotal Phase III studies (HCVerso®). The HCVerso® studies include approximately 1,100 treatment-naïve HCV genotype-1b patients, including those who are interferon eligible or ineligible and patients with compensated liver cirrhosis.