Idera Pharma Says Phase 2 Trial Of IMO-8400 Fails To Meet Primary Endpoint

(RTTNews) - Idera Pharmaceuticals Inc. (IDRA) announced results from the Phase 2 clinical trial of IMO-8400 in adult patients with dermatomyositis. The trial did not meet its primary endpoint of statistically significant change from baseline in the CDASI activity score versus placebo.

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 company said that it 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.