Boehringer Ingelheim Pharmaceuticals, Inc.
Susan Holz
Public Affairs & Communications
Phone (203) 798-4265
usnews@boehringeringelheim.com
900 Ridgebury Rd./P.O. Box 368
Ridgefield, CT 06877-0368
http://us.boehringeringelheim.com
For U.S. Media
Fact Sheet for Media
Research & Development in Hepatitis C Virus
Hepatitis C virus (HCV) is an infectious disease of the liver that, therapeutically, is underserved and a leading cause of chronic liver disease and liver transplant.
Boehringer Ingelheim Research Vision
Despite recent treatment progress, the burden of HCV on patients and physicians remains. Boehringer Ingelheim recognizes the need for an HCV cure that addresses more of the challenges that these patients face.
Boehringer Ingelheim strives to achieve a far reaching and inclusive cure for more HCV patients, including those who are the most difficult to treat. In partnership with the scientific community, our clinical trial program, HCVersoTM, is rigorously designed to find answers to challenges that HCV patients face. The program extends to diverse HCV patient populations across the world, including HIV co-infected patients and those who have previously failed treatment. Our goal is to improve cure rates, shorten treatment and eliminate interferon in HCV treatment for as many patients as possible.
History of Treatment
Pegylated interferon and ribavirin (PegIFN/RBV) have historically been the standard-of-care for treatment of HCV, but are only effective in about half of patients with chronic HCV infection.
Interferon is the backbone of current HCV treatment regimens and is challenging for a number of patients due to contraindications of use, side effects, adherence and treatment duration. Currently available protease inhibitors are approved for use in combination with PegIFN/RBV.
Treatment success is primarily determined by viral genotype, the most common of which are types 1, 2 and 3. HCV genotype-1 patients are the most difficult to treat and often require the longest course of therapy. Genotype-2 and-3 patients typically are more easily treated with only PegIFN/RBV.
The scientists at Boehringer Ingelheim have a long-standing commitment to virology including innovations in HIV/AIDS, and have been focused on HCV for many years. In 2003, these researchers were the first to publish results describing the clinical application of a novel agent that directly targets the HCV protease. This early work spawned today’s significant research effort into new ways of directly inhibiting the virus's ability to replicate, which has led to the Company’s current portfolio of investigational direct-acting HCV antivirals.
Boehringer Ingelheim maintains a Virology Center of Excellence, dedicated to research and drug discovery for viral diseases for which there is no vaccine or where current therapy is lacking.
Across the industry, HCV research is directed towards advancing inhibitors that target essential viral enzymes, such as the HCV serine protease and RNA polymerase. These approaches may lead to the development of novel classes of direct acting antivirals (DAAs), further enhancing the standard-of-care for HCV patients.
Boehringer Ingelheim HCV Portfolio Key Research Areas
From within our HCV pipeline, we are advancing two investigational DAAs: BI 201335, a protease inhibitor that has shown the potential to improve cure rates and shorten treatment duration compared to PegIFN/RBV therapy, as well as BI 207127, a polymerase inhibitor that has the potential to eliminate interferon from HCV treatment when combined with BI 201335 and RBV.
BI 201335
BI 201335 is an investigational, once-daily oral HCV NS3/4A protease inhibitor discovered from Boehringer Ingelheim’s own research and development. A multi-study, Phase 3 clinical trial program is currently underway to evaluate BI 201335 combined with PegIFN/RBV in both treatment-naive and -experienced patients with chronic genotype-1 HCV, as well as HCV/HIV co-infected patients. The trial program is being performed at sites across the world, including Europe, the United States, Canada and Asia Pacific.
BI 201335 binds to a shallow active site on an enzyme critical in HCV replication. The shallow nature of the enzyme active site makes it a challenge to design a molecule with the correct properties to effectively inhibit the enzyme. BI 201335 is optimized to target genotype-1 HCV, the most difficult type to effectively treat with current therapy.
BI 207127
BI 207127 is an investigational NS5B polymerase inhibitor that is currently being evaluated in Phase 2 clinical trials. The HCV NS5B is believed to be the central enzyme responsible for HCV replication. BI 207127 works by blocking a specific step in the viral lifecycle, targeting the polymerase enzyme, and consequently preventing HCV from replicating. BI 207127 is being evaluated as part of combination therapy regimens including BI 201335.
BI 201335 + BI 207127 Combination Therapy without Interferon
A Phase 2b trial (SOUND-C2) evaluating dual DAA treatment, with the combination of BI 207127 and BI 201335 in interferon-free regimens, both with and without ribavirin, in treatment-naïve HCV patients is currently under way. Data from a pre-specified interim analysis of SOUND-C2 show the potential for BI’s DAA compounds in combination with RBV, without interferon.
Planning for Phase 3 interferon-free clinical trials is underway.
FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development programs for BI 201335 in combination with PegIFN/RBV, and the development program for the interferon-free combination of BI 201335 plus BI 207127. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.
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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Contact:
Susan Holz
Boehringer Ingelheim Pharmaceuticals, Inc.
(203) 798-4265
usnews@boehringer-ingelheim.com
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