Positive Interim Results from Interferon-Free Phase 2b SOUND-C2 Study with Boehringer Ingelheim's Two Investigational HCV Direct Acting Antivirals Presented at AASLD

SAN FRANCISCO and RIDGEFIELD, Conn., Nov. 7, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a planned interim analysis of a Phase 2b study, SOUND-C2, that showed the combination of two oral direct acting hepatitis C virus (HCV) compounds – the protease inhibitor BI 201335 and the polymerase inhibitor BI 207127 with ribavirin (RBV) – was successful in reducing viral load below the lower limit of quantifiable levels at week 12 (viral response) in the majority of treatment-naive patients infected with chronic genotype-1 (GT1) HCV. None of the five study arms included treatment with interferon. These data were presented as a late-breaking poster at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, CA.

"Results from the planned interim analysis of SOUND-C2 are encouraging," 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. "They show that BI 201335 plus BI 207127 with ribavirin suppressed the hepatitis C virus to undetectable levels in the majority of patients in this study. We must now complete the study to confirm if this interferon-free regimen leads to a sustained viral response."

"BI is developing our dual oral direct acting antiviral treatment regimen with the goal of eliminating interferon from HCV treatment. We are excited by these interim results and look forward to final study outcomes," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We also are pleased to present other data from our hepatitis C virus portfolio that underscores our ongoing focus on real-world challenges faced by HCV patients, including traditionally difficult-to-treat populations."

The interferon-free oral combination therapy arms with BI 201335, BI 207127 and RBV showed high virologic response rates through week 12 across treatment arms. Viral suppression also was observed in the RBV-sparing arm but was lower than in the other arms at week 12.

• 76 percent of patients who received BI 201335 once daily (QD) plus BI 207127 twice daily (BID) with RBV achieved viral response through week 12.
• 70 percent of patients who received BI 201335 QD plus BI 207127 three times daily (TID) with RBV achieved viral response through week 12.
• 57 percent of patients who received BI 201335 QD plus BI 207127 TID without RBV achieved viral response through week 12.

Breakthrough occurred in 13 percent of patients in BI 201335 plus BI 207127 TID with RBV treatment groups (arms one – three) and in 21 percent of patients in the BI 201335 plus BI 207127 BID with RBV treatment group. Breakthrough occurred in 15 percent of patients in the group that did not receive RBV.

The most frequent adverse events (AEs) were asthenia, pruritus, rash, photosensitivity, jaundice, nausea, vomiting and diarrhea. Across all treatment groups, 6–12 percent of patients discontinued due to AEs.

Results from this open-label, randomized, Phase 2b study were presented as a late-breaking poster titled, "Virologic Response to an Interferon-Free Regimen of BI 201335 and BI 207127, with and Without Ribavirin, in Treatment-Naive Patients with Chronic Genotype-1 HCV Infection: Week 12 Interim Results of the SOUND-C2 Study," by Stefan Zeuzem. In the study, 362 treatment-naive GT1 HCV patients were randomized to receive either:

• BI 201335 120 mg QD plus BI 207127 600 mg TID plus RBV for 16 weeks;
• BI 201335 120 mg QD plus BI 207127 600 mg TID plus RBV for 28 weeks;
• BI 201335 120 mg QD plus BI 207127 600 mg TID plus RBV for 40 weeks;
• BI 201335 120 mg QD plus BI 207127 600 mg BID plus RBV for 28 weeks; or
• BI 201335 120 mg QD plus BI 207127 600 mg TID without RBV for 28 weeks.

Other BI data being presented at the meeting include:

• SILEN-C3: Treatment for 12 or 24 Weeks with BI 201335 Combined with Peginterferon Alfa-2a and Ribavirin (P/R) in Treatment-Naive Patients with Chronic Genotype-1 HCV Infection (Abstract 36. D. Dieterich, et al. November 6, 4:15 p.m. - 4:30 p.m. PT)
• Characterization of HCV NS3 Variants that Emerged During Virologic Breakthrough and Relapse from BI 201335 Phase 2 SILEN-C1 Study (Poster 1339. G. Kukolj, et al. November 7, 8:00 a.m. - 5:00 p.m. PT)
• Treatment with the Second Generation HCV Protease Inhibitor BI 201335 Results in High and Consistent SVR Rates – Results from SILEN-C1 in Treatment-Naive Patients Across Different Baseline Factors (Abstract 226. M.S. Sulkowski, et al. November 8, 8:45 a.m. - 9:00 a.m. PT)
• High Sustained Virologic Response Following Interferon-Free Treatment of Chronic HCV GT1 Infection for Four Weeks with HCV Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127 and Ribavirin, Followed by BI 201335 and PegIFN/Ribavirin – the SOUND-C1 Study (Abstract 249. S. Zeuzem, et al. November 8, 11:15 a.m. - 11:30 a.m. PT)

About Hepatitis C Virus

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 175 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. Chronic HCV infection is the cause of an estimated 8,000 to 10,000 deaths annually in the United States. 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.

About Boehringer Ingelheim in Hepatitis C Virus

Boehringer Ingelheim has a long-standing commitment to virology, including developing innovative therapies for HIV/AIDS and HCV. The company recognizes the significance of the HCV epidemic and continues to work on improving treatment and cure rates for diverse populations of HCV patients through its dedicated HCV treatment development program, called HCVerso™.

Boehringer Ingelheim is advancing BI 201335, an investigational oral HCV NS3/4A protease inhibitor that has the potential to improve cure rates as compared to PegIFN/RBV therapy. A multi-study Phase 3 trial program currently is underway to evaluate BI 201335 combined with PegIFN/RBV in both treatment-naive and -experienced patients with chronic genotype-1 HCV.

Boehringer Ingelheim also is developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has the potential to eliminate interferon from HCV treatment when combined with BI 201335 and RBV. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, with and without RBV, are currently underway.

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.