Clinical Trials
Conatus has conducted a series of clinical trials exploring the activity of CTS-1027 in patients with chronic HCV infection.
The first Phase 2 clinical trial evaluated the anti-inflammatory activity of CTS-1027 as a potential therapy for liver damage associated with chronic infection by hepatitis C virus. As the first trial conducted in chronic HCV infected patients, the study was a dose-finding trial to establish safety and activity in HCV patients who failed to respond to existing approved treatments. This trial was concluded in 2009.
Observations from this initial Phase 2 clinical trial in conjunction with new preclinical data generated by Conatus suggest that CTS-1027 may have a broader role in treating patients with HCV by impacting one or more of the survival strategies used by the hepatitis C virus. Based on these observations, CTS-1027 is currently being evaluated for its antiviral effects alone or in combination with one or both of the current standard of care drugs, pegylated interferon and ribavirin.
In June 2009, Conatus initiated a second Phase 2 clinical trial. This trial includes patients for whom treatment with interferon based therapies is not advised. This clinical trial is a double-blind, placebo-controlled trial testing CTS-1027 alone or in combination with ribavirin in approximately 70 patients for up to 24 weeks. The trial is being conducted in up to 25 medical centers in the U.S. Enrollment and dosing in the trial are complete and data collection is ongoing.
In January 2010, Conatus initiated a third Phase 2 clinical trial in HCV patients. In this open-label trial CTS-1027 is being dosed for up to 48 weeks in combination with pegylated interferon (Pegasys®) and ribavirin (Copegus®) in patients who did not respond to prior standard-of-care treatment. Antiviral activity, safety and tolerability of the triple combination will be assessed in approximately 70 patients. This trial is being conducted at up to 15 medical centers in the U.S. Enrollment in this trial is also complete and patient dosing and follow-up are ongoing.
For more detailed information about this clinical trial, please visit clinicaltrials.gov at the specific web address below:
http://clinicaltrials.gov/ct2/show/NCT00570336?term=CTS-1027&rank=1