Value through Innovation20 October 2014
15 August 2013

Boehringer Ingelheim announces full patient enrolment for two of its pivotal Phase III interferon-free hepatitis C clinical trials

• Over 950 patients have now been successfully enrolled in the pivotal Phase III HCVerso™1 and 2 trials
• The Phase III study programme includes treatment naïve patients, including those ineligible for interferon and patients with liver cirrhosis
• The milestone coincides with the New England Journal of Medicine publication of SOUND-C2: one of the largest interferon-free studies in genoytpe-1 HCV published to date, forming the basis of the HCVerso™ trials

INGELHEIM, 15 August 2013 – Boehringer Ingelheim today announced that enrolment of over 950 treatment naïve genotype-1b patients in the pivotal Phase III interferon-free HCVerso™ 1 and 2 trials is complete.1,2 The trials are investigating the efficacy and safety of Boehringer Ingelheim’s second generation protease inhibitor faldaprevir* and NS5B polymerase inhibitor deleobuvir (BI 207127)*, in combination with ribavirin. HCVerso™ 1 and 2 include difficult-to-treat patient populations such as those who are ineligible for interferon or those with liver cirrhosis.

This important developmental milestone coincides with today’s publication of Boehringer Ingelheim’s Phase IIb interferon-free SOUND-C2 study in the New England Journal of Medicine (NEJM).3 SOUND-C2 showed viral cure rates (sustained virological response, SVR) of up to 85% in patients infected with genotype-1b (GT-1b) hepatitis C virus (HCV). SOUND-C2 investigated the efficacy and safety of faldaprevir* and deleobuvir* plus ribavirin in treatment-naïve patients with genotype-1a and 1b HCV, the most common types of HCV globally. The study included patients with liver cirrhosis (9%), who showed similar rates of viral cure as patients without cirrhosis.4

Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim

Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim

"We are proud to announce the completion of patient recruitment in two of our pivotal HCVerso™ trials. This is an important step towards our goal of delivering an effective and well tolerated cure that will enable patients and doctors to consider an individualised approach for interferon-free HCV therapy," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "The publication of the SOUND-C2 study in the NEJM as well as the speedy recruitment into our pivotal trials provide an indication of the high relevance of interferon-free regimens for the future treatment of HCV. We look forward to the first Phase III results of faldaprevir*, deleobuvir* plus ribavirin in 2014 and the opportunity to explore wider patient populations in the future."

Results from the Phase IIb SOUND-C3 study were also recently presented at the APASL Liver Meeting in Singapore. This follow-up study to SOUND-C2 aimed to further optimise the dosing regimen containing faldaprevir* and deleobuvir* plus ribavirin in treatment-naïve patients (including patients with cirrhosis and those who could not tolerate interferon). SVR rates of 95% were observed in GT-1b infected patients after 16 weeks of treatment.5 The regimen tested in the SOUND-C3 study is now under Phase III evaluation in the HCVerso™ 1 and 2 trials.

Overall tolerability in the SOUND-C trials was good. In the dose-finding study SOUND-C2, 44 of the 362 patients included in the analysis discontinued due to adverse events.3 In SOUND-C3, mild rash and nausea were the most common side-effects. Adverse events of a moderate or higher intensity were rare, with anaemia (16%), fatigue (9%), vomiting (9%) and nausea (9%) being the most frequent adverse events.5

The decision to focus on GT-1b in HCVerso™1 and 2 was based on the higher efficacy seen in this population compared to GT-1a infected patients in the SOUND-C studies (SVR12 in GT-1a patients in SOUND-C2 and SOUND-C3: 58/148 and 2/11 of patients, respectively).3

As part of Boehringer Ingelheim’s long-term commitment to hepatitis C, the company is also evaluating other combinations of investigational hepatitis C compounds that work in different ways. Boehringer Ingelheim’s recent collaboration with Presidio Pharmaceuticals, Inc. for a Phase II clinical study investigating an interferon-free, all-oral combination in GT-1a is part of the company’s continued exploration to discover and develop innovative options for the treatment of HCV.

NOTES TO EDITORS

Newshome

 

The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The Boehringer Ingelheim hepatitis C NewsHome is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media. Visit www.NewsHome.com to find out more.

About HCVerso™
For information on the interferon-free Phase III HCVerso™ trials please refer to the Clinical Trials backgrounder, available on NewsHome.

About Hepatitis C
Hepatitis C is a blood-borne infectious disease caused by the hepatitis C virus which lives and replicates in the liver. Hepatitis C is a leading cause of chronic liver disease, liver cancer and transplantation.6 Chronic hepatitis C is a major public health issue and one of the most prevalent infectious diseases worldwide, affecting around 170 million people,7 with 3-4 million new cases occurring each year.8

It is common for hepatitis C patients to remain undiagnosed due to the initial unspecific symptoms of the disease. Consequently, a large number of patients first present to their physician when they experience symptoms or already have liver disease.9 Patients with advanced liver disease are challenging to cure, yet have the greatest need for more effective and better tolerated treatments.

Of patients with chronic hepatitis C, 20% will develop liver cirrhosis, of which 2-5% will die every year.10 Advanced liver disease due to hepatitis C currently represents the main cause for liver transplantation in the western world.10

About Boehringer Ingelheim in hepatitis C
Through pioneering science, Boehringer Ingelheim is striving to find answers to the pressing challenges still faced by the diverse population of hepatitis C patients. The company’s comprehensively designed hepatitis C clinical trial programme includes a broad range of patients, including the challenging to cure, that clinicians see every day in clinical practice.

Boehringer Ingelheim is developing faldaprevir, an optimised second generation protease inhibitor, as the core component for both interferon-based and interferon-free treatment regimens.

Interferon-based therapy with faldaprevir has the potential to improve cure rates with the added convenience of once-daily dosing and no dietary requirements for intake. Faldaprevir has proven efficacy in a broad range of genotype-1a and 1b hepatitis C patients. The STARTVersoTM trial programme, which includes treatment-naïve, treatment-experienced and HIV co-infected patients with hepatitis C virus, is nearly complete.

Deleobuvir (BI 207127) is a potent investigational non-nucleoside NS5B polymerase inhibitor, in development to treat patients with genotype-1b hepatitis C virus. Phase III HCVersoTM trials, investigating the interferon-free regimen of deleobuvir in combination with faldaprevir+ and ribavirin, are well underway.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

*faldaprevir and deleobuvir are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established

References
1ClinicalTrials.gov. IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1. http://clinicaltrial.gov/ct2/show/NCT01732796?term=faldaprevir+bi+207127&rank=3 [Last accessed 12/07/13]
2ClinicalTrials.gov. Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2. http://clinicaltrial.gov/ct2/show/NCT01728324?term=faldaprevir+bi+207127&rank=2 [Last accessed 12/07/13]
3Zeuzem, S. et al. Faldaprevir and Deleobuvir for HCV Genotype 1 Infection. New England Journal of Medicine. 2013; 369 (7); 630-639 [Available online at: http://www.nejm.org/doi/full/10.1056/NEJMoa1213557]
4Soriano V. et al. Efficacy and safety of the interferon (IFN)-free combination of BI 201335 + BI 207127 ± ribavirin (RBV) in treatment-naïve patients with HCV genotype (GT) 1 infection and compensated liver cirrhosis: Results from the SOUND-C2 study. Abstract#84 presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), 9 – 13 November
5Zeuzem, S. et al. Interferon-Free Treatment with Faldaprevir, BI207127 and Ribavirin in SOUND-C3: 95% SVR12 in HCV-GT1b. Presented at APASL Liver Week, 6-10 June, 2013
6World Health Organisation. Hepatitis C. 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf [Last accessed on 16/07/13]
7Centers for Disease Control and Prevention (2012) Hepatitis C available at: http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-travel/hepatitis-c.htm [Last accessed on 16/07/13]
8World Health Organisation. Hepatitis C Fact Sheet. Updated July 2012 http://www.who.int/mediacentre/factsheets/fs164/en/index.html [Last accessed on 16/07/13]
9 Chen S.L., Morgan T.R. The Natural History of Hepatitis C Virus (HCV) Infection. Int J Med Sci 2006; 3:47-52. Available from http://www.medsci.org/v03p0047.htm [Last accessed on 16/07/13]
10Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009

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