Corbus Pharmaceuticals Holdings has enrolled the first patient in its phase II clinical trial, which will assess the safety and efficacy of Resunab to treat Dermatomyositis, a rare and inflammatory muscle disease accompanied by skin rashes.
Resunab is a novel synthetic oral drug that is claimed to be a preferential agonist to the CB2 receptor expressed on activated immune cells.
Expected to complete in early 2017, the trial is supported 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.
Corbus Pharmaceuticals Holdings chief medical officer Dr Barbara White said: "The dosing of the first subject in this dermatomyositis trial marks an important milestone in our Resunab clinical development programme.
"This is the start of testing Resunab for its ability to provide clinical benefit through resolution of chronic, refractory skin inflammation."
The study will test safety, tolerability, clinical efficacy, biomarkers, and mechanism of action of Resunab in 22 adult subjects, whose skin-predominant dermatomyositis is refractory to standard-of-care.
Under the total treatment duration of 84 days, patients will receive oral Resunab or placebo once a day for 28 days, then twice a day for the next 56 days. The company will then follow-up the trial for 28 days.
Resunab’s pre-clinical and Phase I studies demonstrated a favourable safety, tolerability and pharmacokinetic profile, said Corbus.