Corbus Pharmaceuticals is starting a one-year, open-label extension study for the ongoing Phase 2 clinical trial evaluating the effect of Resunab in patients with skin-predominant dermatomyositis – an inflammatory disease that increases the risk of developing other conditions such as Raynaud’s phenomenon.
The company’s announcement comes in the wake of the U.S. Food and Drug Administration’s review of the extension study, which Corbus submitted to the agency.
Resunab is a synthetic oral drug with a safe and well-tolerated action that activates a group of proteins called CB2 receptors. These receptors are expressed on immune cells and, when activated, trigger molecular pathways that resolve inflammation and halt fibrosis.
The ongoing Phase 2 trial (NCT02466243) is evaluating the safety, tolerability and effectiveness of Resunab in patients with skin-predominant dermatomyositis in whom previous treatment with hydroxychloroquine has failed.
The trial, developed by the University of Pennsylvania School of Medicine, is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health (NIH).
Initial results from the Phase 2 trial are expected in early 2017.
The extension study aims to prolong Resunab treatment for an additional year after the initial phase of the trial is complete, and to continue the evaluation of the safety and effectiveness of the medication over time.
“There is a clear unmet need for effective therapeutic options for individuals living with skin-predominant dermatomyositis,” Victoria Werth, MD, from the Penn School of Medicine, said in a news release.
“Since the launch of the study, individuals have been very receptive to participating, and we look forward to further understanding the long-term safety and efficacy of [Resunab] through this open-label extension study,” she said.
Barbara White, MD, chief medical officer of Corbus, said the company is pleased to offer patients who complete the blinded part of the study the opportunity to continue to receive Resunab for a year.
“The safety and efficacy data generated in this extended period will be valuable to the clinical advancement of [Resunab],” White said.
Resunab is also being studied as a treatment for systemic sclerosis, a disease also often associated with Raynaud’s. According to Corbus CEO Yuval Cohen, PhD, both systemic sclerosis and dermatomyositis are auto-immune disorders that may share a similar onset mechanism of inflammation and fibrosis.
If proven to be effective in treating these conditions, Resunab may become a promising treatment for auto-immune disorders and reduce the risk of developing Raynaud’s phenomenon.