Positive interim results from Idera Pharmaceuticals' IMO-2125 Phase 1 clinical trial for HCV

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:

• All dose levels of IMO-2125 were well tolerated for the four weeks of treatment
• 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
• 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