Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced today preliminary data from a 4-week dose-ranging Phase 1 clinical trial of IMO-2125 in combination with ribavirin in 60 treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. In the trial, treatment with IMO-2125 in combination with ribavirin was well tolerated and achieved substantial decline in virus levels at two days after the first dose of IMO-2125 and after four weeks of treatment. IMO-2125 is a Toll-like Receptor 9 (TLR9) agonist which stimulates production of natural interferons and other antiviral cytokines.
“Based on the overall data from this trial and our Phase 1 clinical trial of IMO-2125 in null-responder HCV patients, our next step in clinical development will be a 12-week Phase 2 trial of IMO-2125 in combination with ribavirin in treatment-naïve HCV patients”
"In this study, IMO-2125 plus ribavirin was well tolerated with no treatment-related discontinuations, and demonstrated substantial antiviral activity," said Robert Arbeit, M.D., Vice President of Clinical Development at Idera. "We believe that IMO-2125 may provide an alternative immune modulatory component to pegylated interferons in the anticipated HCV therapy combinations using direct-acting antivirals. In this treatment scenario, effective stimulation of the host immune system through TLR activation could minimize the risk of viral breakthrough."
"Based on the overall data from this trial and our Phase 1 clinical trial of IMO-2125 in null-responder HCV patients, our next step in clinical development will be a 12-week Phase 2 trial of IMO-2125 in combination with ribavirin in treatment-naïve HCV patients," said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer at Idera. "We expect that the objectives of the Phase 2 study will be to determine optimal dosing, provide longer-term safety data and generate additional antiviral activity data in support of the future clinical development of IMO-2125."
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