Phase 3 data show viral cure rates achieved in a broad range of patients with genotype-1 hepatitis C taking investigational compound faldaprevir plus PegIFN/RBV

Ridgefield, CT, November 2, 2013– Boehringer Ingelheim Pharmaceuticals, Inc. today announced new data from its Phase 3 clinical trial program, STARTVerso^™, which evaluates the investigational protease inhibitor, faldaprevir, in combination with pegylated interferon and ribavirin (PegIFN/RBV). The Phase 3 clinical program includes trials in treatment-naïve (STARTVerso^™1&2 - NCT01343888, NCT01297270), treatment-experienced (STARTVerso^™3 - NCT01358864), and HIV/HCV coinfected (STARTVerso^™4 - NCT01399619)  patients with genotype-1 (GT1) hepatitis C (HCV).  The primary efficacy endpoint of all trials is viral cure 12 weeks after the conclusion of treatment (SVR12).

In a pooled analysis of treatment-naive, gentotype 1 patients (STARTVerso^™1&2), 73% (382/521) and 72% (378/524) of all patients treated with 120mg or 240mg of faldaprevir once-daily, both in combination with PegIFN/RBV, respectively, achieved SVR12. In comparison, 50% (131/264) of patients treated with PegIFN/RBV alone achieved SVR12. Also in the pooled analysis, 84% (436/521) of patients who received a regimen including 120mg of faldaprevir once-daily were eligible for an overall shortened time on treatment of 12 weeks on faldaprevir and 24 weeks on PegIFN/RBV. Of these patients, 83% (362/436) achieved SVR12.

In treatment-experienced patients (STARTVerso^™3), 12 weeks of faldaprevir-based treatment (240mg once-daily), in combination with PegIFN/RBV,demonstrated SVR12 of 70% (69/99) in patients who relapsed on previous HCV treatment, compared to 14% (7/49) of patients taking PegIFN/RBV alone. In patients who partially responded to previous treatment, 58% (33/57) achieved SVR12, compared to 3% (1/29) of patients taking PegIFN/RBV alone. In patients who showed no response to previous treatment, 33% (48/145) achieved SVR12.

Additionally, early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso^™4) showed that 74% (229/308) of patients treated with a faldaprevir-based regimen (120mg or 240mg once-daily), in combination with PegIFN/RBV, had undetectable HCV at four weeks following treatment completion (SVR4). The study includes patients coinfected with HCV and HIV who were treatment-naïve or had relapsed after previous HCV therapy with PegIFN/RBV, and were either HIV treatment-naïve or being treated with ART.

The results from these and additional studies will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting^®, taking place November 1-5 in Washington, D.C.

“HCV patients have various treatment needs, and this data studying an interferon-based regimen may be particularly encouraging for those with advanced liver disease, including cirrhosis, who may need treatment urgently,” said Douglas Dieterich, M.D., professor of medicine in the Division of Liver Diseases, Mount Sinai School of Medicine.

More than 2,200 patients have been studied in the STARTVerso^™ trial program, including a large proportion of patients with difficult-to-cure types of HCV:

• Over 300 patients in the STARTVerso^™ program have HIV/HCV coinfection (STARTVerso^™4); these patients are known to have lower response rates to treatment and are therefore considered difficult to cure. In this trial, 14% of patients are African American
• 677 patients in the STARTVerso^™ program (STARTVerso^™3) are treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure
• 40% of patients in STARTVerso^™3 (treatment-experienced patients) have advanced liver disease (≥F3 fibrosis)
• 59% of patients in STARTVerso^™1&2 (treatment-naïve patients) have a non-CC IL28B genotype; in previous studies, these patients have been less likely to achieve viral cure

“These pivotal data from STARTVerso^™ are important for Boehringer Ingelheim’s HCV portfolio as they support the filing of a New Drug Application for faldaprevir with the Food and Drug Administration,” said Peter Piliero, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These results take us a step closer towards our goal of making faldaprevir available for patients who urgently need HCV treatment.”

In the STARTVerso^™ clinical trial program, adverse events (AEs) most commonly included nausea, fatigue, diarrhea, headache, anemia, weakness, rash and jaundice due to transient bilirubin elevation (unconjugated hyperbilirubinemia). In STARTVerso^™1&2, anemia occurred in 14%, 13%, and 14% of patients taking 120mg and 240mg faldaprevir regimens or PegIFN/RBV alone, respectively. Hyperbilirubinemia occurred in 12% (120mg), 46% (240mg) and less than 1% (PegIFN/RBV) of patients, and was transient. ALT elevations in the faldaprevir arms were similar to placebo, and occurred in 2% (120mg), 2% (240mg) and 3% (PegIFN/RBV) of patients. Gastrointestinal side effects occurred in 11% (120mg), 18% (240mg) and 7% (PegIFN/RBV) of patients. Rash occurred in 7% (120mg), 10% (240mg) and 4% (PegIFN/RBV) of patients. There was no occurrence of photosensitivity in the faldaprevir 120mg arm, and a 1% occurrence in the 240mg arm. Bilirubin associated AEs occurred in 3% (120mg), 9% (240mg) and 1% (PegIFN/RBV) of patients. Further, AEs leading to the discontinuation of faldaprevir occurred in 1% (120mg) and 3% (240mg) of patients.

In STARTVerso^™3, AEs of at least moderate intensity in the 12- and 24-week faldaprevir arms included gastrointestinal side effects, which occurred in 20% (12-week), 17% (24-week) and 6% (PegIFN/RBV alone) of patients. Anemia occurred in 10% of patients in both faldaprevir arms (12- and 24-week) and 5% of patients taking (PegIFN/RBV alone). Rash, photosensitivity, and jaundice occurred in ≤ 5% of faldaprevir patients (12- or 24-week arms). Further, AEs leading to the discontinuation of faldaprevir occurred in 7% (12-week) and 8% (24-week) of patients. In STARTVerso^™4 to date, nausea has occurred in 28% and 44% of patients taking 120mg and 240mg faldaprevir regimens, respectively. Additionally, fatigue has occurred in 32% (120mg) and 35% (240mg) of patients, diarrhea has occurred in 25% (120mg) and 28% (240mg) of patients, headache has occurred in 24% (120mg) and 25% (240mg) of patients, asthenia has occurred in 26% (120mg) and 21% (240mg) of patients, and decreased appetite has occurred in 24% (120mg) and 20% (240mg) of patients. Thus far, discontinuation of faldaprevir due to AEs leading to the discontinuation of faldaprevir has occurred in 1% (120mg and 240mg) of patients. Serious AEs occurred in 14% (120mg) and 8% (240mg) of patients, resulting in one death from Stevens-Johnson syndrome (SJS) with onset 145 days after discontinuing treatment while on systematic antibiotics.

Additional Boehringer Ingelheim Data at the Meeting
Additional late breaking data from Boehringer Ingelheim’scollaborative interferon-free trial with Presidio Pharmaceuticals will be presented on Monday, November 4. This ongoing Phase 2a study evaluates a 12-week, all-oral regimen of Boehringer Ingelheim’s investigational compounds, faldaprevir and deleobuvir, in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.

Further, data from other Boehringer Ingelheim studies will be presented at AASLD. The aim of these studies is to better understand faldaprevir’s drug-drug interaction profile in patients who are taking birth control and common anti-addiction medications. Additionally, a study evaluating faldaprevir in patients who have renal impairment will also be presented. Studies have shown that there is a higher prevalence of chronic kidney disease, also known as renal impairment, in patients with HCV making it important to understand the activity of HCV treatments in this population.  

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

Abstracts from The Liver Meeting^® can be accessed on the AASLD website at www.aasld.org.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to cure. Our pivotal HCV clinical trials for faldaprevir and deleobuvir are comprised of two multi-trial programs, STARTVerso^™ and HCVerso^®.

Faldaprevir is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver. Boehringer Ingelheim is developing faldaprevir as a core component of both interferon-based and interferon-free hepatitis C treatment regimens. STARTVerso^™ is a multi-study Phase 3 trial program that evaluates faldaprevir combined with PegIFN/RBV. The four trials that make up this program study the combination in treatment-naïve, treatment-experienced and HIV/HCV coinfected patients with chronic genotype-1 HCV. Deleobuvir 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. As part of our long-term commitment to HCV, the company is exploring other combinations of investigational HCV compounds that work in complementary ways. The recent collaboration of Boehringer Ingelheim with Presidio Pharmaceuticals, Inc. for a Phase 2a clinical study investigating an interferon- and ribavirin-free, all-oral combination is part of the company’s continued commitment to discover and develop innovative options for the treatment of HCV.

STARTVerso^™ and HCVerso^® are registered service marks of Boehringer Ingelheim International GmbH.

The Liver Meeting^® is a registered trademark of the American Association for the Study of Liver Diseases (AASLD).

Hepatitis C is a blood-borne 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, approximately 3.2-5.2 million people have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, which accounts for 10,000 -12,000 deaths in the United States per year.

About Boehringer Ingelheim
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 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.

For more information please visit www.us.boehringer-ingelheim.com.

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