Idera
Delays Study of TLR9 Agonist IMO-2125 for Hepatitis C
SUMMARY
Idera Pharmaceuticals has decided to hold off on a planned
clinical trial of its experimental hepatitis C drug IMO-2125,
pending further toxicity data from ongoing animal studies. |
Below
is an edited excerpt from an Idera press release explaining the
latest developments.
Idera
Pharmaceuticals Delays Initiation of Phase 2 Clinical Trial of
IMO-2125 (Toll-Like Receptor-TLR-9 agonist) in Treatment-Naive
HCV Patients
Cambridge,
Mass. -- April 22, 2011 -- 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-naive, 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.
4/26/11
Source
Idera
Pharmaceuticals. Idera Pharmaceuticals Delays Initiation of Phase
2 Clinical Trial of IMO-2125 (Toll-Like Receptor -TLR-9 agonist)
in Treatment-Naive HCV Patients. Press release. April 22, 2011.
