Corbus Pharmaceuticals Expands Development of Resunab™ With Phase 2 Trial Treatment of Dermatomyositis

Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) announced that its Phase 2 clinical study with Resunab™ for the treatment of skin-predominant dermatomyositis is open for enrollment.

As quoted in the press release:

Dermatomyositis is a rare, inflammatory muscle disease that is accompanied by skin rashes and affects up to approximately 25,000 individuals in the United States. The pathology can involve serious pulmonary, cardiovascular, and gastrointestinal involvement, has a significant burden of illness, and impairs daily functioning and quality-of-life. There are currently no FDA-approved therapies specific for dermatomyositis, and physicians commonly treat manifestations of the disease with immunosuppressive therapies that have significant toxicities.

The Phase 2 clinical trial is funded by a grant from the National Institutes of Health (“NIH”) to the University of Pennsylvania School of Medicine. Victoria P. Werth, M.D., Professor of Medicine at the University of Pennsylvania School of Medicine and Chief, Dermatology, Philadelphia V.A. Hospital, is the Principal Investigator for the clinical trial. The Phase 2 trial will test safety, tolerability, clinical efficacy, biomarkers, and mechanism of action of Resunab in skin-predominant dermatomyositis. The study plans to enroll 22 adults whose skin disease is refractory to standard-of-care. These adults will receive oral Resunab or placebo once a day for 28 days, then twice a day for the next 56 days, for a total treatment duration of 84 days, with 28 days follow-up. The study is expected to end in early 2017.

Barbara White, M.D., chief medical officer of Corbus Pharmaceuticals, commented:

We are grateful for this opportunity to work in close collaboration with Dr. Werth and the NIH to test the safety and efficacy of Resunab in dermatomyositis in this Phase 2 trial. Through its ability to activate endogenous pathways that resolve inflammation, Resunab has the potential to provide much-needed clinical benefit to these dermatomyositis patients with refractory disease. As a clinical researcher and dermatologist actively involved in treating patients with dermatomyositis and other autoimmune diseases of the skin, I look forward to investigating Resunab’s safety, efficacy, and impact on the disease in this patient population with skin-predominant dermatomyositis. There is a huge unmet need for safe and effective therapies for patients with dermatomyositis.

Click here to read the full Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) press release.