Experimental Treatment for Dermatomyositis Fails to Meet Endpoints in Phase 2 Trial

According to a story from globenewswire.com, the biopharmaceutical company Idera Pharmaceuticals recently released the data from its Phase 2 trial for IMO-8400, an investigational product in development for the treatment of dermatomyositis. Idera Pharmaceuticals is a clinical stage company that is focused on developing treatments for rare cancers and rare diseases.

Dermatomyositis is a long term, inflammatory disorder that primarily affects the skin and muscles. While the mechanism of the disease is an autoimmune response, the cause of dermatomyositis is generally unclear. Common theories suggest that cancer or a viral infection could trigger the initial autoimmune response. Up to 30 percent of cases are linked to cancer; the most common types that are associated with dermatomyositis are breast cancer, ovarian cancer, and lung cancer. A portion of cases also appear to be inherited. Symptoms include a skin rash, which can take several forms, such as scaly papules on the finger joints, a v-shape on the chest, around the eyes with swelling, along the back and shoulders, and upper arms and thighs. People with dermatomyositis also experience progressive muscle weakness that begins in the thighs and shoulders, making movement difficult. There is no cure, but symptoms can be treated. To learn more about dermatomyositis, click here.

The goal of the Phase 2 trial was primarily to evaluate the safety and effectiveness of IMO-8400. Effectiveness would be measured by changes from baseline in a measure of skin disease severity called the Cutaneous Dermatomyositis Disease Area and Severity Index (“CDASI”). A total of 30 patients participated in the trial. They received weekly injections of either IMO-8400 or a placebo for a duration of 24 weeks. Many patients were experiencing severe disease even after prior treatment with corticosteroids or other immunosuppressive therapies.

Unfortunately, IMO-8400 failed to demonstrate significant improvement for patients over the group that used a placebo. This failure means that further research into IMO-8400 will most likely be discontinued. While the results are disappointing for everyone involved, the group most let down here are certainly the patients; there are simply a very limited array of treatment options for dermatomyositis. If disease is so severe that it does not respond to conventional treatments, then there is currently little that patients can do.

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