|Boehringer Ingelheim enrols first patients in pivotal Phase III interferon-free hepatitis C trial programme|
Wednesday, 23 January 2013 14:03
Phase III HCVerso™ trial design focuses on genotype-1b patients following positive Phase IIb data in this population
INGELHEIM, Germany, 17 January 2013 – Today, Boehringer Ingelheim announced that the first patients have been enrolled in the company’s pivotal Phase III interferon (IFN)-free hepatitis C (HCV) clinical trial programme, HCVerso™. Boehringer Ingelheim’s IFN-free investigational polymodal* regimen combines faldaprevir (BI 201335)+, a next wave once-daily protease inhibitor, and BI 207127+, a non-nucleoside polymerase inhibitor, plus ribavirin.
The HCVerso™ clinical trial programme includes two Phase III IFN-free clinical trials that will treat approximately 1,000 treatment-naïve HCV genotype-1b (GT-1b) patients.1,2 The decision to focus the Phase III trials on this patient group follows positive Phase IIb trial data from the SOUND-C studies, where Boehringer Ingelheim’s IFN-free investigational polymodal* regimen showed high viral cure rates in patients with GT-1b HCV, the most prevalent type of HCV globally.3
New preliminary results from the SOUND-C3 trial show that 100 percent (n=20) of HCV patients with GT-1b achieved viral elimination when measured four weeks (SVR4) after completing a 16 week course of treatment. These data further support the choice of this patient population for Phase III. Full results from SOUND-C3 are expected in early 2013.
"We are proud to announce that the first patients have now been enrolled in our Phase III interferon-free clinical trial programme, HCVerso™," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "“HCV patients will benefit most from an individualised treatment approach since host genetics, viral genotype and stage of liver disease vary from patient to patient. Our interferon-free investigational polymodal* regimen has shown particular promise in treating patients with genotype-1b HCV so we have decided to focus our Phase III trial programme on this population. Our goal is an interferon-free future in the treatment of HCV and ensuring all patients individually receive the most effective treatment for them."
Results from the SOUND-C2 study, which were presented in November 2012 at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), found that up to 85 percent of GT-1b HCV patients treated with different IFN-free regimens of faldaprevir, BI 207127 and ribavirin achieved viral cure at 12 and 24 weeks following treatment completion (SVR12 and SVR24).3
Eliminating injectable interferon from treatment regimens is a critical goal in HCV as it can be challenging for patients, due to the long treatment duration and often severe side-effects. Up to 50 percent of patients may not be eligible for treatment with interferon and of those eligible, less than 80 percent of patients with the most common type of chronic HCV, genotype-1, achieve a viral cure with current interferon based triple therapies.4 The severe side-effects of interferon, including heart failure, sepsis, leukopenia, depression and vision loss, contribute to low medication adherence, ultimately leaving many patients in need uncured.5,6 Since 1999, there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007 alone.7
"More effective and tolerable alternatives to interferon would help patients with their decision to start and to stay on treatment, which is imperative to achieve the ultimate goal of a virologic cure," said lead study investigator Christoph Sarrazin, M.D., Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. "I’m pleased the trial design includes a diverse population of genotype-1b patients, particularly those with liver cirrhosis, reflecting the types of patients we see every day in clinical practice."
The HCVerso™ clinical trial programme includes two Phase III IFN-free clinical trials that will treat approximately 1,000 treatment-naïve HCV genotype-1b (GT-1b) patients. Trial sites are planned for many different countries around the world, including the US, Germany, Canada, and Australia.
HCVerso 1 1
In this Phase III study, more than 460 treatment-naïve GT-1b HCV patients will be treated. Patients will be randomised (1:1) into two treatment arms. A third, open label arm will treat up to 70 cirrhotic patients.
HCVerso 2 2
Data from the HCVersoTM studies are expected in late 2013.
|Last Updated on Thursday, 24 January 2013 07:49|