Conatus Pharmaceuticals Inc announced the initiation of a phase-II clinical trial evaluating CTS-1027 in combination with pegylated interferon (Pegasys) and ribavirin (Copegus) in refractory HCV patients. Antiviral activity, safety and tolerability of the triple combination will be assessed after up to 48 weeks of therapy.
"There is a significant unmet medical need in HCV patients who have not responded to pegylated interferon and ribavirin. These patients often progress to cirrhosis, a life-threatening condition. CTS-1027 has the potential to increase the effectiveness of the combination of pegylated interferon and ribavirin in this population," said Dr Paul J Pockros, head, Division of Gastroenterology and director of the SC Liver Research Consortium and The Scripps Clinic in La Jolla, CA.
CTS-1027 is an oral, small molecule compound that inhibits the activity of key members of a class of protease enzymes, the matrix metalloproteinases or MMPs. CTS-1027’s anti-inflammatory and anti-fibrotic effects have been well-established in models of acute hepatitis and liver fibrosis. In addition, CTS-1027 has been shown to reduce and/or block HCV replication in in vitro preclinical models.
This clinical trial is an open-label design testing an optimized dose of CTS-1027 in combination with Pegasys and Copegus in HCV-infected patients who were prior null responders to pegylated interferon and ribavirin treatment. Dosing will last for up to 48 weeks. The Company expects approximately 60 patients to be enrolled. The clinical trial will be conducted at up to fifteen medical centers in the US.
"Our studies suggest that CTS-1027 treatment has the potential to amplify the effectiveness of pegylated interferon and ribavirin therapy. We believe that treating the most refractory patients will give us the best indication as to whether CTS-1027 can enhance the activity of existing therapy," said Steven J Mento, president and CEO of Conatus. "The field is moving towards combinations of small molecules, and CTS-1027 represents a novel approach that we hope will benefit patients infected with HCV."
Conatus Pharma is a privately-held specialty pharmaceutical company engaged in the development of innovative human therapeutics to treat liver disease.