Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that it has chosen to delay initiating its planned Phase 2 clinical trial of IMO-2125 based on preliminary data from a 26-week nonclinical toxicology study of IMO-2125 in rodents. The Phase 2 clinical trial involves the evaluation of IMO-2125 plus ribavirin in treatment-naïve, genotype 1 hepatitis C virus (HCV) patients.
“IMO-2125 has been evaluated in 96 HCV-infected patients in two Phase 1 studies and no treatment-related serious adverse events or treatment-related discontinuations have been observed.”
Idera is conducting chronic 26-week nonclinical toxicology studies of IMO-2125 in rodents and non-human primates. Preliminary analysis of the histology data from the rodent study showed instances of atypical lymphocytic proliferation. The Company expects data from the non-human primate study and additional histology data from the rodent study during the second half of 2011.
"Conduct of the planned 12-week Phase 2 trial of IMO-2125 was supported by previously completed 13-week nonclinical toxicology studies in rodents and non-human primates. However, given the preliminary 26-week nonclinical toxicology data, we have decided to delay initiating the Phase 2 trial. We plan to determine our path forward after we have fully evaluated the data from our chronic nonclinical toxicology studies of IMO-2125," said Sudhir Agrawal, D.Phil, Chairman and Chief Executive Officer at Idera. "IMO-2125 has been evaluated in 96 HCV-infected patients in two Phase 1 studies and no treatment-related serious adverse events or treatment-related discontinuations have been observed."
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