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news.Conatus Pharmaceuticals (Conatus) has initiated 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.
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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.
Reportedly, the clinical trial is an open-label design testing an optimised 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.
The company said that in the study the 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.
Steven Mento, president and CEO of Conatus, said: “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. 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.”