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Idera Pharmaceuticals Delays Initiation of Phase 2 Clinical Trial of IMO-2125 (Toll-Like Receptor -TLR - 9 agonist) in Treatment-Naïve HCV Patients (animal tox)
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CAMBRIDGE, Mass.--(BUSINESS WIRE)--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."
About IMO-2125
IMO-2125, a Toll-like Receptor (TLR) 9 agonist, is a novel immune modulator being developed as a component of treatment for chronic hepatitis C virus (HCV) infection. IMO-2125 is designed to stimulate the immune system, causing the body to generate natural interferons and other antiviral cytokines. IMO-2125 has been evaluated in a Phase 1 clinical trial in null-responder HCV patients as monotherapy for four weeks and in a Phase 1 clinical trial in treatment-naïve HCV patients in combination with ribavirin for four weeks.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat chronic hepatitis C virus infection, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. The company's proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors. Idera's pioneering DNA and RNA chemistry expertise enables us to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit www.iderapharma.com.
Contacts
Idera Pharmaceuticals, Inc.
Teri Dahlman, 617-679-5519
tdahlman@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
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