Corbus Pharmaceuticals has received a development award for up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT). The funding will help support a Phase II clinical trial of the Corbus’ oral anti-inflammatory drug Resunab™ in adults with cystic fibrosis (CF).
Resunab is a synthetic oral drug that has been shown to resolve inflammation and progressive fibrosis. According to Corbus, Resunab has a favorable safety profile coupled with promising potency in preclinical models of inflammation and fibrosis. The drug binds to a receptor called CB2 on activated immune cells and triggers resolution of inflammation and reduction of pro-inflammatory pathways, in effect, turning chronic inflammation “off” without causing immunosuppression, the company said. Resunab can also stop the influx of new inflammatory cells into the tissue and act directly on fibroblasts to reduce their production of collagen that promotes fibrosis.
Corbus said it has been working closely with CFFT on the design of the Phase II trial protocol. “We believe that Resunab has the potential to treat the pulmonary inflammation and fibrosis that play such a key role in the disease progression of CF, affecting both the quality of life and life expectancy in people with the disease,” said Yuval Cohen, Ph.D., CEO of Corbus. “Further, Resunab has the potential to address CF in individuals regardless of the specific mutation they have.”
“This CFFT development award highlights the importance of targeting inflammation in the treatment of CF and marks an important step forward in the advancement of new approaches for treating CF,” said James Chmiel, M.D., a specialist in pediatric pulmonary diseases and associate director the Division of Pediatric Pulmonology, Allergy, Immunology and Sleep Medicine and of the LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies & Children's Hospital, who will serve as co-principal investigator of the study.
Corbus has submitted its Phase II clinical protocol to FDA and anticipates initiating the study of Resunab this quarter.
The funding is the second initiative CFFT has engaged in this month. A week ago, the organization said it agreed to expand a collaboration from November 2011 with Genzyme in a $14 million deal aimed at developing new treatments for people with F508del, the most common CF mutation.