The objective of the multi-center, global, Phase 2, randomized, double blind, placebo-controlled trial was to assess the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), disease-specific autoantibodies and immunogenicity of IMO-8400 in adult patients with dermatomyositis. The primary objective of the trial was to assess the change from baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index ("CDASI") activity score, an outcome measure of skin disease severity, versus placebo.
30 eligible subjects were randomized to 1 of 3 treatment groups to receive once weekly subcutaneous injections of 0.6 or 1.8 mg/kg of IMO-8400 or placebo for up to 24 weeks. The mean CDASI activity score was in the severe range in all three cohorts despite background treatment with immunosuppressive drugs and/or systemic corticosteroid drugs in 17 of the 30 subjects.
The trial did not meet its primary endpoint of statistically significant change from baseline in the CDASI activity score versus placebo.
The company would like to recognize the efforts of the investigators from this trial and importantly the patients who entered this trial in the hope that IMO-8400 may have been an effective treatment for their disease.
Harnessing the approach of the earliest researchers in immunotherapy and the Company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy.
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Source: Idera Pharmaceuticals, Inc.