Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program

RIDGEFIELD, Conn., Jan. 17, 2013 /PRNewswire/ -- Today, Boehringer Ingelheim Pharmaceuticals, Inc. announced that the first patients have been enrolled in the company's pivotal Phase 3 interferon (IFN)-free hepatitis C (HCV) clinical trial program, HCVerso™. Boehringer Ingelheim's investigational IFN-free regimen combines the compounds faldaprevir (BI 201335), a protease inhibitor administered once-daily, and BI 207127, a non-nucleoside polymerase inhibitor administered twice-daily, plus ribavirin. Phase 3 clinical trial sites are established in more than 25 states in the U.S.

The HCVerso™ clinical trial program includes two pivotal Phase 3 IFN-free studies that will enroll approximately 1,000 treatment-naive HCV genotype-1b (GT-1b) patients, including those who are interferon eligible or ineligible. The decision to enroll GT-1b patients in the Phase 3 trials follows results from the Phase 2b SOUND-C studies, where Boehringer Ingelheim's investigational, IFN-free regimen showed higher viral cure rates* in patients with the 1b HCV genotype, the most prevalent type of HCV globally.

New preliminary results from the SOUND-C3 trial show that 100 percent (n=20) of patients with HCV GT-1b  achieved sustained virologic response four weeks (SVR4) after completing a 16 week course of treatment. Two patients experienced serious adverse events and two patients discontinued treatment early due to adverse events in SOUND-C3. Four patients in this study had compensated liver cirrhosis (damaged or scarred liver tissue). These data further support the trial design for Boehringer Ingelheim's pivotal HCVerso™ study. Full results from SOUND-C3 are expected in 2013.

"We are proud to announce that the first patients are now enrolled in our Phase 3 HCVerso™ program, including at U.S. trial sites," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Patients infected with HCV may benefit most from an individualized treatment approach since a person's genetics, type of virus, and stage of liver disease vary from patient to patient. Our investigational interferon-free regimen has shown particular promise in treating patients with HCV genotype-1b so we have decided to enroll these patients in our Phase 3 trial program. Our goal is for an interferon-free future and ensuring patients are treated with the most effective treatment for them individually."

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 patients infected with HCV GT-1b treated with Boehringer Ingelheim's investigational IFN-free regimen of faldaprevir, BI 207127 and ribavirin achieved viral cure at 12 and 24 weeks following treatment completion (SVR12 and SVR24).

Eliminating injectable interferon from treatment regimens is a critical goal in HCV as it can be difficult for patients to take due to long treatment duration and often severe side-effects. In addition, up to 50 percent of patients may not be eligible for treatment with interferon. Severe side-effects of interferon include heart failure, sepsis, leukopenia, depression and vision loss, resulting in adherence problems and treatment failure for many patients. 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.

"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 very frequently in clinical practice."

Boehringer Ingelheim Interferon-free Phase 3 Trial Designs
The Phase 3 trial program includes two pivotal studies:
HCVerso 1
This Phase 3 study will enroll treatment-naive patients infected with HCV GT-1b. Patients will be randomized (1:1) into two treatment arms. A third, open-label arm will enroll cirrhotic patients.

• Group 1: 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
• Group 2: 16 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV followed by an additional 8 weeks of placebo
• Group 3 (patients with compensated liver cirrhosis): 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV

HCVerso 2
This Phase 3 study will enroll treatment-naive patients infected with HCV GT-1b, and includes patients who are eligible or ineligible for interferon. Patients will be randomized (1:1) into two treatment arms. A third, open-label arm will enroll cirrhotic patients.

• Group 1: 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
• Group 2: 8 weeks of placebo followed by 16 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
• Group 3 (patients with compensated liver cirrhosis): 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV

Data from the HCVerso™ studies are expected in late 2013.

For more information regarding the trials, please visit www.clinicaltrials.gov.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
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.

Faldaprevir, also known as BI 201335, is an investigational, oral HCV NS3/4A protease inhibitor that may improve viral cure rates as compared to PegIFN/RBV therapy alone, and has completed clinical trials through Phase 2b (SILEN-C studies). Faldaprevir is designed to target the hepatitis C viral reservoir in the liver and inhibit viral replication. The ongoing multi-study Phase 3 STARTVerso™ trial program, evaluating faldaprevir combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV, is near clinical completion. BI 207127 is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso™ trials investigating this regimen are now underway.

Faldaprevir and BI 207127 are investigational compounds and not approved by the FDA. Their safety and efficacy have not been established.

Hepatitis C is a blood-born infectious disease and 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. 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.

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.

*Sustained virologic response (SVR) 12 and 24 weeks following treatment completion

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.