Corbus Pharmaceuticals Holdings, Inc. a clinical stage drug development company targeting chronic, rare, and serious inflammatory and fibrotic diseases with clear unmet needs, recently announced the initiation of patient enrollment for its Phase 2 trial of Resunab™ for the treatment of diffuse cutaneous systemic sclerosis.
Systemic Sclerosis (Scleroderma) is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases with an unclear etiology. Scleroderma is found in two forms: limited and diffuse, with the diffuse form being most severe, affecting around 50,000 people in the United States. About 80% of those affected by scleroderma are women, with an onset typically in mid-life. There are currently no FDA-approved drugs for the treatment of systemic sclerosis.
Barbara White, M.D., Chief Medical Officer of the Company, commented in a recent news release, “The launch of this study is an important milestone in the clinical development of Resunab. More importantly, Resunab has the potential to provide an entirely new approach to treat people with systemic sclerosis, who clearly need effective therapies without adversely suppressing their immune system.”
Resunab™ is a first in class, oral anti-inflammatory drug that acts to resolve inflammation. In chronic inflammatory diseases, the body is unable to turn off heightened inflammatory responses. Resunab is designed to trigger the resolution of chronic inflammation by binding to and activating the CB2 receptor on immune cells (in effect, turning inflammation “off”). Resunab holds 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.
The clinical trial will be conducted in multiple centers specialized in systemic sclerosis across the US, and will be led by 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.
Dr. Spiera commented, “Resunab has anti-inflammatory and anti-fibrotic effects that are so relevant to the disease process in systemic sclerosis. We are hopeful that Resunab has the potential to address the significant unmet need for effective treatments that improve skin and lung involvement and other disease manifestations in people with this devastating disease. Currently there are limited treatments for these patients, and the mechanism of action of Resunab through induction of SPMs has the potential to provide clinical benefit to them.”
The Phase 2 study is a Randomized, Double-blind, Placebo-controlled Multicenter trial to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Resunab in Diffuse Cutaneous Systemic Sclerosis. A total of 36 patients with systemic sclerosis will be treated for 84 days with a follow up period of 28 days. The trial is expected to last 16 months. The study will also examine clinical outcomes assessed by the Combined Response Index for Systemic Sclerosis, or CRISS score.
Resunab’s effect on patient-reported outcomes, as well as its mechanism of action and effect on biomarkers in patients with systemic sclerosis will also be evaluated.
“We are pleased to have met all of the regulatory requirements (FDA, DEA, IRB) to begin enrolling patients in this clinical study. The launch of this trial represents the second clinical study now underway with Resunab, following the launch of our Phase 2 dermatomyositis study last quarter and we are on schedule for the imminent launch of our Phase 2 trial of Resunab for the treatment of cystic fibrosis,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. “Once these three parallel Phase 2 trials are all launched, each in a distinct rare inflammatory disease, we will have implemented our initial clinical plans with Resunab and significantly increased the potential value of our lead product candidate. We look forward to data from these studies which we expect at the end of 2016.”
This June, Resunab as a treatment for systemic sclerosis was granted Orphan Drug Designation by the FDA. The drug was also recently granted Fast Track status for there SSc indication, helping to accelerate Resunab’s development toward a possible FDA approval.