- Category: HCV Treatment
- Published on Friday, 09 November 2012 00:00
- Written by Press Release
Merck and Co. announced last week that it plans to start 2 new clinical trials to evaluate its investigational hepatitis C virus (HCV) protease inhibitor MK-5172 in all-oral regimens containing ribavirin with or without the company's early-stage NS5A inhibitor MK-8742. Both studies will enroll previously untreated genotype 1 chronic hepatitis C patients.
Below is an edited excerpt from a Merck press release describing the forthcoming studies in more detail.
Merck Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational, Once-Daily, Oral Treatment for Chronic Hepatitis C Virus
Whitehouse Station, NJ. -- November 2, 2012 -- Today, Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced plans to initiate two new clinical trials with MK-5172, its investigational, once-daily, oral HCV NA3/4A protease inhibitor for the treatment of chronic hepatitis C (HCV) infection. The trials are designed to assess the efficacy and safety of MK-5172 in all-oral, interferon-free combination regimens in non-cirrhotic, treatment-naive patients with chronic HCV genotype 1 infection.
"For more than 30 years, Merck has been leading innovation in viral hepatitis. The science is advancing rapidly, and we recognize that future HCV treatment regimens will not include interferon," said Roger Pomerantz, MD, FACP, senior vice president and Global Franchise Head for Infectious Diseases, Merck Research Laboratories. "The start of these new studies is the next step in our efforts to develop novel therapeutic regimens for the treatment of chronic hepatitis C. We look forward to evaluating the potential role of MK-5172 and our other earlier pipeline candidates for chronic HCV as part of our continuing commitment to improving patient care."
The first clinical trial will evaluate a 12-week regimen containing MK-5172, MK-8742, an oral NS5A inhibitor in Phase I development, and ribavirin in non-cirrhotic treatment-naive patients with HCV genotype 1 infection. The second clinical trial will evaluate 12- and 24-week regimens of MK-5172 in combination with ribavirin in non-cirrhotic treatment-naive patients with HCV genotype 1 infection with an IL-28 CC genotype. More information is available at http://clinicaltrials.gov using identifiers, NCT01717326 and NCT01716156, respectively.
MK-5172 is an investigational, once-daily, oral HCV NS3/4A protease inhibitor currently in Phase II development that has demonstrated potent in vitro antiviral activity. Early data on MK-5172 has shown a broad HCV genotypic activity spectrum and in vitro activity against genotype 1a and 1b viral variants that have been associated with resistance to other HCV protease inhibitors, including those in development. Given the clinical experience of MK-5172 to date, including its potentially high barrier to resistance and antiviral activity across HCV genotypes, Merck will evaluate MK-5172 in treatment regimens in a broad spectrum of patients with chronic HCV infection.
Merck's Global Commitment to Advancing Hepatitis Therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies for our marketed and investigational medicines for the treatment of chronic HCV, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Merck and Co. Merck Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational Once-Daily, Oral Treatment for Chronic Hepatitis C Virus. Press release. November 2, 2012.