Idera Pharmaceuticals Begins Phase 1 Trial of Toll-like Receptor Agonist IMO-2125 for Chronic Hepatitis C

Idera Pharmaceuticals announced last week that the first participants have started treatment in a Phase 1 study of the company's investigational toll-like receptor 9 (TLR 9) antagonist, designated IMO-2125. Toll-like receptors play a role in immune response, including stimulating interferon production. The new trial is looking at IMO-2125 plus ribavirin in previously untreated patients with hepatitis C virus (HCV) genotype 1. Idera researchers will present findings from earlier studies of IMO-2125 at the AASLD Liver Meeting later this month.

Below is an excerpt from Idera's recent press release describing the study.

Idera Pharmaceuticals Initiates Phase 1 Clinical Trial
of IMO-2125, a TLR9 Agonist, in Combination with
Ribavirin for Chronic Hepatitis C Virus Infection

Cambridge, MA -- October 7, 2009 -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that patient treatment has been initiated in a phase 1 clinical trial evaluating IMO-2125 in combination with ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) infection. IMO-2125 is a novel agonist of Toll-like Receptor (TLR) 9.

"We expect that the IMO-2125 trial with ribavirin in treatment-naive HCV patients and our ongoing IMO-2125 monotherapy trial in HCV patients who failed to respond to previous standard of care therapy will provide us with data in two HCV patient populations on safety, immunological activity, and effect on HCV RNA levels," said Tim Sullivan, PhD, Vice President of Development Programs. "We plan to use the data from these ongoing trials to guide us in further clinical development of IMO-2125 in the treatment of chronic HCV infection."

About the Trial

The phase 1 randomized, placebo-controlled clinical trial evaluating IMO-2125 in combination with ribavirin is being conducted in treatment-naive patients with genotype 1 chronic HCV infection. IMO-2125 is administered subcutaneously once a week for four weeks in combination with daily oral administration of standard doses of ribavirin. The target enrollment is 15 patients per cohort, with 12 randomized to receive IMO-2125 plus ribavirin treatment and three randomized to receive placebo plus ribavirin treatment. The primary objective of the trial is to assess the safety and tolerability of IMO-2125 over an escalating range of dosages in combination with standard doses of ribavirin. In addition, the effect of treatment on HCV RNA levels will be monitored. The clinical trial is expected to be conducted at five or more sites in France and Russia.

Upcoming Presentations on IMO-2125 at the 60th Annual Meeting of the American Association for the Study of Liver Diseases

The company's two abstracts have been published and can be accessed on the AASLD website. The abstracts are:

	Abstract 1593: "IMO-2125, a TLR9 agonist, induces Th-1 type cytokines and interferons with potent anti-HCV activity in human peripheral blood mononuclear cells and plasmacytoid dendritic cells"
	Abstract 1597: "Gene expression profiles induced by IMO-2125, an agonist of Toll-like receptor 9, in human peripheral blood mononuclear cells"

The posters will be presented on Tuesday, November 3, at 8:00AM ET.

About IMO-2125

IMO-2125 is a novel DNA-based TLR9 agonist being evaluated for the treatment of chronic HCV infection. IMO-2125 was designed to induce endogenous interferon-alpha along with other immune response factors to treat hepatitis C. In preclinical studies, the immune response factors induced by IMO-2125 have potent activity alone and in combination with ribavirin in HCV replicon assays. In addition to the announced trial, IMO-2125 is also being evaluated as a monotherapy in an ongoing phase 1 randomized, placebo-controlled clinical trial for the treatment of patients with chronic HCV infection who have failed to respond to previous standard of care combination therapy of ribavirin and pegylated interferon-alpha.

About the IMO-2125 Monotherapy Trial

In this trial, IMO-2125 is administered subcutaneously once a week with four weeks of treatment. The target enrollment is ten patients per cohort, with eight randomized to receive IMO-2125 treatment and two randomized to receive placebo treatment. The trial is designed to assess the safety and tolerability of IMO-2125 over an escalating range of dose levels and to determine the effect of IMO-2125 on HCV RNA levels and parameters of immune system activation. The trial is being conducted at six U.S. sites.

About Idera Pharmaceuticals, Inc.

Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. Our proprietary drug candidates are designed to modulate specific Toll-like Receptors (TLRs), which are a family of immune system receptors that direct immune system responses. Our pioneering DNA and RNA chemistry expertise enables us to create drug candidates for our internal development programs and our partnered programs, and generates opportunities for additional collaborative alliances.

For more information, visit www.iderapharma.com.

10/13/09

Source
Idera Pharmaceuticals, Inc. Idera Pharmaceuticals Initiates Phase 1 Clinical Trial of IMO-2125, a TLR9 Agonist, in Combination with Ribavirin for Chronic Hepatitis C Virus Infection. Press release. October 7, 2009.