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news.Idera Pharmaceuticals has decided not to immediately commence its IMO-2125 Phase 2 clinical trial on the basis of preliminary data from a 26-week nonclinical toxicology study of IMO-2125 in rodents.
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IMO-2125 is a novel immune modulator being developed as a component of treatment for chronic hepatitis C virus (HCV) infection.
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.
In the Phase 2 trial, the company is planning to evaluate IMO-2125 plus ribavirin in treatment-naive, genotype 1 hepatitis C virus (HCV) patients.
Preliminary analysis of the histology data from the rodent study demonstated instances of atypical lymphocytic proliferation.
Idera Pharma chairman and CEO Sudhir Agrawal said 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.
"We plan to determine our path forward after we have fully evaluated the data from our chronic nonclinical toxicology studies of IMO-2125," Agrawal said.