Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, today announced that the company has commenced enrollment in a Phase 2 clinical trial of IMO-8400, an investigational TLR 7, 8 and 9 antagonist, in patients with dermatomyositis. Dermatomyositis is a rare and debilitating inflammatory muscle and skin disease associated with significant morbidity, decreased quality of life and an increased risk of premature death.
"We are very pleased to initiate this clinical trial for patients living with dermatomyositis," stated Kate Haviland, Idera's Vice President of Rare Diseases. "Based on preclinical and clinical studies demonstrating the role of Toll-like receptors in dermatomyositis and other immune-mediated inflammatory diseases, we believe IMO-8400 has the potential to play an important role in the treatment of this serious disease. In partnership with leading global myositis experts, we carefully designed this new Phase 2 trial in dermatomyositis to define the safety and efficacy profile of IMO-8400, as well as contribute data that will advance the myositis community's understanding of the disease."
"The myositis community is excited by the start of this important clinical trial," said Bob Goldberg, Executive Director of The Myositis Association. "Dermatomyositis is a severe and disabling disease that can limit the ability of patients to perform activities of daily living, maintain employment and lead full independent lives. For many patients, currently available treatments do not effectively control their disease and/or are not well tolerated. New targeted therapies such as IMO-8400 will hopefully improve patient outcomes."
The Phase 2, randomized, double-blind, placebo-controlled clinical trial is designed to assess the safety, tolerability and treatment effect of IMO-8400 in adult patients with dermatomyositis. Eligibility criteria include evidence of active skin and muscle involvement. Once enrolled, patients will be randomized to 1 of 4 groups to receive once weekly subcutaneous injections of: placebo, or 0.06 mg/kg, 0.2 mg/kg, or 0.6 mg/kg of IMO-8400 for a period of 24 weeks. The study is expected to enroll approximately 48 patients and is being conducted at approximately 20 centers in the United States and United Kingdom. The primary efficacy endpoint is the change from baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), a validated outcome measure of skin disease. Additional exploratory endpoints include muscle strength and function, the International Myositis Assessment & Clinical Studies Group (IMACS) core set measures, patient-reported quality of life and biochemical markers of disease activity.