Idera Pharmaceuticals, a clinical stage biopharmaceutical company developing nucleic acid therapeutics for patients with cancer and rare diseases, and The Myositis Association (TMA), the only nonprofit organisation dedicated to solely serving all patients with inflammatory myopathies, announced a collaboration to advance a new potential treatment approach for polymyositis and dermatomyositis known as Toll-like receptor (TLR) antagonism.

Under the terms of the collaboration, Idera and TMA will develop educational programmes and resources for patients and healthcare providers, including interactive online chats, on TLR antagonism and opportunities to participate in upcoming clinical research. Idera plans to initiate a clinical trial of its investigational drug candidate IMO-8400, a first-in-class antagonist of TLRs in polymyositis and dermatomyositis by the end of 2014.

“We are very excited and pleased to work with TMA, a leading myositis patient advocacy association that shares our commitment to advancing new therapies that may improve outcomes for patients living with this rare and painful inflammatory muscle disease,” said Kate Haviland, vice president of Rare Diseases at Idera Pharmaceuticals. “As we prepare to move our investigational drug candidate IMO-8400 into clinical development for polymyositis and dermatomyositis, we believe that TMA will be instrumental in increasing patient and physician awareness and excitement for opportunities to participate in clinical research involving TLR antagonism.”

“TMA is very pleased to collaborate with Idera to help advance their novel TLR antagonist therapeutic approach in myositis,” said Bob Goldberg, Executive Director of The Myositis Association. “We believe that the work Idera is doing will further the myositis medical field and our understanding of how to better treat patients suffering from this debilitating rare disease.”

Polymyositis and dermatomyositis are devastating, rare inflammatory myopathies that cause inflammation and progressive weakness in muscles. Polymyositis and dermatomyositis patients can develop serious disabilities, including loss of mobility, difficulty breathing and swallowing, and have an increased risk of certain cancers. Dermatomyositis is also accompanied by a purple or red skin rash. There are an estimated 15,000 polymyositis patients and 25,000 dermatomyositis patients in the US alone. Both polymyositis and dermatomyositis have been designated as rare diseases by the US Food and Drug Administration (US FDA).

The Myositis Association (TMA) was founded in 1993 by Betty Curry, a patient who identified the need for information and support for inclusion-body myositis patients; then quickly grew to include the other forms of myositis dermatomyositis and polymyositis. TMA is the only nonprofit organisation dedicated to solely serving patients with the inflammatory myopathies. Besides offering free membership to patients, TMA publishes online and print materials for patients and physicians, offers 45 support groups in the US and conducts an Annual Patient Conference and Myositis Symposium to connect international myositis experts with the myositis medical and patient communities. TMA’s research programme has funded 37 grants and fellowships, totaling more than $4.4 million, in the past 11 years.

Idera’s Toll-like receptor (TLR) antagonist drug candidates have been created using a proprietary chemistry-based drug discovery platform. IMO-8400 is a first-in-class synthetic oligonucleotide-based antagonist of TLRs. In April 2014, Idera presented preclinical data at the American Association for Cancer Research Annual Meeting from preclinical studies in which IMO-8400 inhibited the survival and proliferation of human B-cell lymphoma cells harboring the oncogenic MYD88 L265P genetic mutation. IMO-8400 also has shown activity in preclinical studies of autoimmune diseases, including psoriasis, lupus, and arthritis. IMO-8400 has been well-tolerated in a Phase 1 trial in 42 healthy subjects at single and multiple escalating doses up to 0.6 mg/kg for four weeks, and has shown inhibition of immune responses mediated by TLRs. In March 2014, Idera announced top-line data from an ongoing Phase 2 trial that showed evidence of clinical activity in patients with psoriasis who were treated with IMO-8400 at doses of up to 0.3 mg/kg/week for 12 weeks. Idera is pursuing clinical development of IMO-8400 in genetically defined forms of B-cell lymphoma, including Waldenström’s macroglobulinemia and diffuse large B-cell lymphoma harboring the MYD88 L265P mutation, and in rare autoimmune diseases, including polymyositis, dermatomyositis and graft versus host disease.