FDA Approves Corbus’ Extension Study of Scleroderma Drug Resunab

The U.S. Food and Drug Administration (FDA) approved Corbus Pharmaceuticals’ 12-month, open-label extension study of its ongoing Phase 2 clinical trial of Resunab for the treatment of diffuse cutaneous systemic sclerosis (scleroderma).

The extension study aims to offer all participants the option of receiving Resunab after they complete the 84-day, Phase 2, multi-center, double-blind, randomized, placebo-controlled trial (NCT02465437) assessing Resunab’s safety and tolerability in up to 36 people with systemic sclerosis. Corbus Pharmaceuticals expects to report top-line data from the trial in the fourth quarter of this year.

The open label extension study aims to collect additional long-term data on the efficacy and safety of Resunab. All patients who agree to enroll in the 12-month extension study will receive Resunab, including patients treated with a placebo in the Phase 2 trial. The same outcome measures assessed in the Phase 2 trial will be monitored during the extension study, namely treatment-emergent adverse events and changes in terms of lung function, skin scores, disability, and global health assessment.

“There is a clear unmet need for effective therapy options for individuals living with systemic sclerosis. Since the launch of the study, individuals have been very receptive to participating, and we look forward to furthering our understanding of the long-term safety and efficacy of Resunab through this open-label extension study,” said principal investigator Robert Spiera, M.D., director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City, in a press release.

“We are delighted to be able to offer the patients in our systemic sclerosis trial the opportunity to continue in a 12-month, open-label extension study of Resunab, upon their competition completion of the blinded portion of the trial,” said Barbara White, M.D., chief medical officer of Corbus. “The additional 12 months of safety and efficacy data will be invaluable to the clinical advancement of this promising drug.”

Resunab is a first-in-class, synthetic oral endocannabinoid-mimetic drug that binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Resunab has the potential to be a safe and potent anti-inflammatory drug with a unique mechanism of action to treat a range of chronic inflammatory diseases.

“This is a noteworthy clinical milestone for Corbus, and we would like to express our gratitude to the subjects and the clinical study teams participating in the study. We are grateful for the opportunity to further the clinical development of Resunab,” said Corbus CEO Yuval Cohen, Ph.D.

In 2015 the FDA granted Orphan Drug status and Fast Track designation to Resunab for the treatment of systemic sclerosis.