Phase 2b Study of Boehringer Ingelheim's Interferon-Free Hepatitis C Treatment Shows Undetectable Virus in HCV Genotype-1 Patients 12 Weeks After Treatment Ended (SVR12)

BARCELONA, Spain and RIDGEFIELD, Conn., April 19, 2012 /PRNewswire/ -- New data from a pre-specified interim analysis of the Phase 2b SOUND-C2 study show that 68 percent of genotype-1 (GT1) hepatitis C virus (HCV) patients achieved sustained viral response 12 weeks after the end of treatment (SVR12) with Boehringer Ingelheim's investigational direct-acting antiviral compounds – the protease inhibitor BI 201335 and polymerase inhibitor BI 207127 – plus ribavirin (RBV), without interferon. SVR12 has been highly correlated with SVR24, which is a recognized indicator of viral cure. These patients received combination therapy with BI 201335 once-daily (QD), BI 207127 twice-daily (BID) and RBV for 28 weeks. The SOUND-C2 study investigated interferon-free treatment in HCV GT1 patients, the most difficult genotype to treat, regardless of IL-28B status. Among study participants, 10 percent had compensated liver cirrhosis.

"Eliminating interferon from HCV treatment is an urgent need," said Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, and lead investigator of the study. "The antiviral activity of BI's all oral direct-acting antiviral compounds in the SOUND-C2 study demonstrates the potential for an interferon-free cure for HCV."

Furthermore, a separate arm of the SOUND-C2 study showed that after 16 weeks of interferon-free treatment, SVR12 was achieved in 59 percent of patients. Investigators presented relapse data broken out by genotype and IL-28B status. The rate of relapse in the treatment arms ranged between 2 and 10 percent for GT1b and GT1a-CC patients. There was a higher rate of relapse in GT1a non-CC patients, with relapse ranging from 0 to 40 percent. The full results from this interim analysis of SOUND-C2 are being presented on Saturday, April 21, at the International Liver Congress, the 47th Annual Meeting of the European Association of the Study of the Liver (EASL 2012) in Barcelona, Spain (Abstract #101). These results supplement the abstract findings highlighted today during an official EASL press conference.

"We are looking forward to the final results from this study, that we hope will be a significant step towards an interferon-free future for patients with HCV," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to the millions of people around the world who are chronically infected with HCV. Through our clinical trial program HCVerso™, we are working with experts worldwide to ask the difficult questions that remain in HCV to find answers to the challenges that these patients face."

Planning of the interferon-free Phase 3 clinical trial program is underway.

SOUND-C2 Pre-Specified Interim Analysis

In this open-label Phase 2b study, 362 treatment-naive GT1 HCV patients were randomized into five interferon-free treatment groups, each with 120 mg BI 201335 QD, but with different dosing of BI 207127 and treatment durations. The randomization was stratified by HCV genotype (1a or 1b) and patient IL-28B genotype, with 41 percent of patients being GT1a and 75 percent being IL-28B CT or TT.

Investigators reported breakthrough broken out by genotype and IL-28B status. In GT1b and GT1a-CC patients, breakthrough occurred in 7 percent of patients in Arm A, 11 percent of patients in Arm B, 19 percent of patients in Arm C, 9 percent of patients in Arm D, and 29 percent of patients in Arm E (no RBV arm). In GT1a non-CC patients, breakthrough occurred in 40 percent of patients in Arm A, 50 percent of patients in Arm B, 25 percent of patients in Arm C, 64 percent of patients in Arm D, and 91 percent of patients in Arm E (no RBV arm).

In this study, the most common adverse events (AEs) were skin (photosensitivity, rash), gastrointestinal (GI) disorders (vomiting, diarrhea), and jaundice due to unconjugated hyperbilirubinemia. Treatment discontinuations due to AEs correlated with increased dosing frequency and treatment duration, with discontinuations ranging from 4.9 percent in Arm A (16 weeks) to 24.7 percent in Arm C (40 weeks). In the arm with BID dosing of BI 207127 (Arm D), discontinuations were 7.7 percent. BID dosing of BI 207127 is planned for Phase 3 investigation.

Other BI data being presented at the EASL Annual Meeting include:

About Hepatitis C Virus (HCV)

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 170 million people globally, with three to four million new infections occurring each year. 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. The majority – about 75 to 85 percent – of HCV cases will develop into chronic infection. It is estimated 20 percent of patients with chronic HCV will develop cirrhosis within 20 years of infection. The mortality rate after cirrhosis has developed is 2 – 5 percent per year. Chronic HCV infection is the cause of an estimated 8,000 to 10,000 deaths annually in the United States.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)

Boehringer Ingelheim has a long-standing commitment to virology, including developing innovative therapies for HCV and HIV/AIDS. Through pioneering science, BI strives to achieve a far reaching and inclusive HCV cure that may ease the impact of the disease. In partnership with the scientific community, our clinical trial program, HCVerso™, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat.

BI 201335, an investigational oral HCV NS3/4A protease inhibitor that has shown the potential to improve cure rates as compared to PegIFN/RBV therapy alone, has completed clinical trials through Phase 2b (SILEN-C studies). A multi-study Phase 3 trial program currently is underway to evaluate BI 201335 combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV.

BI 207127, an NS5B RNA-dependent polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined with BI 201335 and RBV, is currently being investigated in Phase 2 trials in interferon-sparing regimens.

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.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.