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Corbus begins dosing in Phase II trial of Resunab to treat dermatomyositis

Corbus Pharmaceuticals has started dosing patients in a Phase II clinical trial of its investigational drug Resunab to treat skin-predominant dermatomyositis.

Resunab is a new synthetic oral drug that is a preferential agonist to the CB2 receptor expressed on activated immune cells.

The company noted that CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis.

University of Pennsylvania School of Medicine professor of Dermatology and Medicine and Corporal Michael J. Crescenz VAMC Dermatology chief Victoria Werth is the principal investigator of the trial.

The Phase II trial is funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health to the University of Pennsylvania School of Medicine and is expected to be completed in early 2017.

Dr Werth noted: "Unfortunately, in the US there are no FDA-approved treatments specific to dermatomyositis, and many patients have persistent disease with the currently available therapies.

"Based on its favorable safety profile and mechanism of action in pre-clinical and prior clinical studies, I believe Resunab may offer the potential to safely and effectively address a huge unmet medical need for individuals with skin-predominant dermatomyositis."

About 22 adult patients whose skin-predominant dermatomyositis is refractory to standard-of-care will be included in the trial, which is designed to evaluate the safety, tolerability, clinical efficacy, biomarkers and mechanism of action of Resunab.

During the trial, patients will be given 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.