Dec 21 2009
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced positive
interim results from a Phase 1 clinical trial of IMO-2125 in patients
with chronic hepatitis C virus infection (HCV). IMO-2125 is an agonist
of Toll-like Receptor 9 that Idera designed to treat HCV by inducing
endogenous interferon-alpha and other Th1-type cytokines and chemokines.
“We believe that the mechanism of IMO-2125 which induces endogenous
interferon-alpha may provide advantages over the use of recombinant
interferon in the null responder HCV patient population”
In this four-week trial, IMO-2125 was well tolerated and induced
dose-dependent increases in endogenous interferon-alpha and other
cytokines. IMO-2125 also demonstrated a treatment-related decrease in
viral load at escalating dose levels. All patients enrolled in the trial
are null responders, which is defined as patients who have failed to
achieve a 2 log10 reduction in viral load during previous 12 to 24 weeks
of treatment with pegylated recombinant interferon-alpha plus ribavirin,
the current standard of care treatment.
“The interim data in the difficult-to-treat null responder HCV patient
population through the first four dose levels of IMO-2125 in this
four-week trial are very encouraging,” said Tim Sullivan, Ph.D., Vice
President of Development Programs. “Based on these data, we are
extending the trial to a fifth dose level and beginning to recruit
patients in this cohort.”
“We believe that the mechanism of IMO-2125 which induces endogenous
interferon-alpha may provide advantages over the use of recombinant
interferon in the null responder HCV patient population,” said Sudhir
Agrawal, D.Phil., Chief Executive Officer and Chief Scientific Officer.
“We plan to use the results from this ongoing clinical trial to guide
our strategy for further development of IMO-2125 for the null responder
HCV patient population. In addition, we have ongoing a second clinical
trial of IMO-2125 in combination with ribavirin in treatment-naïve HCV
patients, the results of which will guide our development strategy for
IMO-2125 in this patient population.”
Interim results through four dose levels of IMO-2125 are as follows:
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All dose levels of IMO-2125 were well tolerated for the four weeks of
treatment
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IMO-2125-treated patients showed dose-dependent increases in
endogenous interferon-alpha, interferon-inducible protein 10 (IP-10),
and 2’,5’-oligoadenylate synthetase (2’,5’-OAS) concentrations
-
At dose levels from 0.08 to 0.32 mg/kg, an increasing percentage of
patients ranging from 40 to 75% achieved a maximum reduction in viral
load of 1 log10 or more at least once during the treatment period
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None of the patients who received placebo treatment or IMO-2125 at the
0.04 mg/kg dose level showed a maximum reduction in viral load of 1
log10 or greater at any time during the treatment period
Source Idera Pharmaceuticals, Inc.