A Phase 3 Dermatomyositis Trial has Completed Enrollment

According to a story from GlobeNewswire, the drug development company Corbus Pharmaceuticals Holdings, Inc., has recently announced that it has completed its enrollment of patients for an upcoming phase 3 clinical trial. This trial will test the company’s experimental drug lenabasum as a therapy for dermatomyositis, a rare disease. Corbus is prioritizing developing transformative medicines designed to act on the endocannabinoid system.

About Dermatomyositis

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.

About the Trial

The study will include a total of 176 subjects, which makes it the largest double-blind, placebo-controlled, randomized dermatomyositis clinical trial ever. The study is international in scope and is being conducted in the US, Asia, and Europe. Patients will receive either placebo, a 20 mg dose of lenabasum two times per day, or a 5 mg dose of lenabasum two times per day. The main treatment period will last 52 weeks along with a one month long follow up period.

The main endpoint of this study will be based on results from the American College of Rheumatology (“ACR”)/ European League Against Rheumatism 2016 Total Improvement Score. There are also plans for an open-label extension period following the conclusion of the study, which would allow patients to continue treatment. The drug has earned Orphan Drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). 

 

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