Corbus Pharmaceuticals to Commence Phase 3 Study of Lenabasum for the Treatment of Rare Autoimmune Disease Dermatomyositis

Corbus Pharmaceuticals Holdings (NASDAQ:CRBP) has announced that it will proceed with a Phase 3 trial evaluating the efficacy and safety of lenabasum for treating dermatomyositis.

As quoted in the press release:

Dermatomyositis is a rare and serious multisystem inflammatory autoimmune disease affecting muscle and skin. The U.S. Food and Drug Administration (“FDA”) provided guidance on the overall study design of this trial at a recent end-of-Phase 2 meeting. The Phase 3 study is planned to begin at the end of 2018.

The international Phase 3 trial will be a 1-year, double-blind, randomized, placebo-controlled study testing efficacy and safety of lenabasum in approximately 150 adults with DM. Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome will be American College of Rheumatology (“ACR”)/ European League Against Rheumatism 2016 Total Improvement Score (“TIS”) in myositis, a composite measure of improvement from baseline in six endpoints: Physician Global Activity, Patient Global Activity, Health Assessment Questionnaire, Manual Muscle Testing, and measurement of muscle enzymes and extra muscular activity. Change in the Cutaneous Dermatomyositis Activity and Severity index (“CDASI”) activity score will be a secondary efficacy outcome.

“Current treatment options for DM patients are largely restricted to immunosuppressive drugs, including high-dose corticosteroids as first-line treatment,” said Barbara White, Chief Medical Officer of Corbus. “DM is a rare disease, the unmet medical need for new treatments is great, and lenabasum treatment was associated with improvement in multiple efficacy outcomes in the Phase 2 study. Our goal is to approach the FDA about registration of lenabasum for treatment of DM should the data from this single Phase 3 study be positive. Dermatomyositis and systemic sclerosis, another rare and serious autoimmune disease in which lenabasum is currently in Phase 3 testing, share many clinical manifestations and aspects of disease pathophysiology. Our confidence in moving into Phase 3 testing in DM is anchored in consistent and often medically meaningful improvements in multiple physician- and patient-reported outcomes in Phase 2 testing in both diseases.”

Click here to read the full press release.