Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) has granted a $5 million development award to clinical stage drug developer Corbus Pharmaceuticals Holdings to support the development process of its investigational drug Resunab to treat cystic fibrosis (CF). The funding from the CFFT, which is the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation (CFF), will be used in the first-in-patient phase 2 clinical trial of the oral anti-inflammatory drug.
Corbus is focused on providing a novel and more effective treatment for the genetic and chronic disease that affects the normal function of the lungs and digestive system. CF is a life-threatening disease caused by a defect in CFTR protein that causes accumulation of thick, sticky mucus in the lungs. CF patients are more likely to suffer bacterial infections, inflammation and consequent lung damage that can lead to pulmonary failure.
“We have been working closely with CFFT on the design of our Phase 2 trial protocol and are honored by the decision to help fund this study,” stated in a press release the CEO of Corbus Pharmaceuticals, Yuval Cohen, PhD. “The Corbus team has an unwavering commitment to the development of breakthrough therapies to treat individuals with cystic fibrosis.”
“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. Further, Resunab has the potential to address CF in individuals regardless of the specific mutation they have,” said Cohen.
Resunab features a unique activity expected to stop inflammation and progression of fibrosis. The effectiveness of the synthetic oral drug was already demonstrated in pre-clinical studies, as well as its safety profile. The treatment works by connecting the CB2 receptor on activated immune cells in order to trigger inflammation resolution and reduce the pro-inflammatory pathways.
The result is that the chronic inflammation is turned off without causing immunosuppression. Resunab is also able to stop the influx of new inflammatory cells into the tissue and acts directly on fibroblasts to reduce collagen production that promotes fibrosis. “Addressing inflammation and the lung damage associated with cystic fibrosis has been a very challenging problem for people with the disease. We believe Resunab has the potential to make a difference in the lives of individuals with CF,” explained Corbus’ Board chairman, Alan F. Holmer.
The company has initiated the phase 2 clinical studies of Resunab recently by submitting the clinical protocol to the U.S. Food and Drug Administration (FDA) for the treatment of adults with CF. Corbus is now awaiting approval of the protocol to start clinical trials, which is expected to happen in the second quarter of this year.
“As a clinician and researcher focused on cystic fibrosis, I believe Resunab has encouraging potential as a novel, new therapy for CF,” stated the specialist in pediatric pulmonary diseases, James Chmiel, M.D., M.P.H. “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. I am looking forward to the outcome of the upcoming clinical study.”