October 1, 2012
Ridgefield, CT, October 1, 2012 – New data from Boehringer Ingelheim’s hepatitis C virus (HCV) clinical development program, HCVersoTM, have been accepted for presentation at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 9 – 13 in Boston, MA.
Results from all arms of SOUND-C2, a Phase 2b trial evaluating an investigational interferon-free HCV treatment, along with other analyses of the trial program will be presented at the meeting. The data will include results of a comparison of SVR4, 12 and 24 from the SOUND-C2 study, and virologic and pharmacokinetic evaluations. SVR is defined as sustained viral response after treatment ends, and is considered viral cure after 24 weeks. Collectively, these data underscore the company’s focus on finding answers to the challenges faced by HCV patients and treaters.
“We are looking forward to sharing the full results of our Phase 2 interferon-free trial, and other HCVersoTM clinical trial data, at the upcoming AASLD meeting in November,” said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Through a robust HCV development program, BI is striving to deliver new solutions with real-life patient needs at the core.”
Boehringer Ingelheim’s abstracts can be accessed through the AASLD website today, www.aasld.org.
Oral Presentations
| Title | Lead Author | Presentation Details |
|---|---|---|
| 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 | V. Soriano | ID# 84 Parallel Session 12: HCV New Agents: Hard to Treat Patients Date: Sun, Nov. 11 Time: 6:00 – 6:15 PM ETLocation: Hynes: Ballroom B & C |
| Interferon (IFN)-free combination treatment with the HCV NS3/4A protease inhibitor BI 201335 and the nonnucleoside NS5B inhibitor BI 207127 ± ribavirin (R): Final results of SOUND-C2 and predictors of response | S. Zeuzem | ID# 232 Parallel Session 34: HCV Clinical Trials: New Agents and Interferon-free Date: Tues, Nov. 13 Time: 11:30 – 11:45 AM ETLocation: Auditorium |
Poster Presentations
| Title | Lead Author | Presentation Details |
|---|---|---|
| SOUND-C2: SVR4, 12, and 24 concordance in genotype (GT) 1 HCV patients receiving interferon (IFN)-free treatment with the HCV NS3/4A protease inhibitor BI 201335 and the NS5B polymerase inhibitor BI 207127 | S. Zeuzem | ID# 778 Session: Clinical HCV 1 Date: Sun, Nov. 11 |
| HCV NS3 and NS5B variants that emerged in patients with virologic breakthrough and relapse from the Phase II SOUND-C2 trial investigating interferon-free BI 201335 and BI 207127 therapy ± ribavirin | A. Côté-Martin | ID# 788 Session: Clinical HCV 1 Date: Sun, Nov. 11 Time: 8:00 AM – 5:30 PM ET Location: Poster Hall |
| Pharmacokinetics of the interferon-free combination of BI 207127 and BI 201335 plus ribavirin in treatment naïve patients with genotype (GT) 1 HCV: Results from the SOUND-C1 study | J. Sabo | ID# 777 Session: Clinical HCV 1 Date: Sun, Nov. 11 Time: 8:00 AM – 5:30 PM ET Location: Poster Hall |
| Analysis of baseline polymorphisms and persistence of emergent variants from Phase Ib and II trials evaluating the HCV NS3 protease inhibitor BI 201335 | K. Berger | ID# 785 Session: Clinical HCV 1 Date: Sun, Nov. 11 Time: 8:00 AM – 5:30 PM ET Location: Poster Hall |
| Addition of the NS5B polymerase inhibitor BI 207127 to pegylated interferon and ribavirin (PegIFN/RBV) for 4 weeks followed by PegIFN/RBV for 44 weeks improves SVR24 rates in treatment-naïve patients with HCV genotype (GT) 1 and is well tolerated | A. Lohse | ID# 767 Session: Clinical HCV 1 Date: Sun, Nov. 11 Time: 8:00 AM – 5:30 PM ET Location: Poster Hall |
About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program, HCVersoTM, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat.
Faldaprevir, also known as BI 201335, is an investigational oral HCV NS3/4A protease inhibitor that may improve cure rates as compared to PegIFN/RBV therapy alone, and has completed clinical trials through Phase 2b (SILEN-C studies). The ongoing multi-study Phase 3 STARTVersoTM trial program, evaluating faldaprevir combined with PegIFN/RBV in treatment-naïve, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV, is near clinical completion. BI 207127 is an NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVersoTM trials investigating this regimen will commence later this year.
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Chronic HCV leads to an estimated 8,000 to 10,000 deaths annually in the United States.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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.
For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.
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