Corbus Pharmaceuticals Announces Presentation of Positive Data on Resunab(TM) in Pre-Clinical Models of Cystic Fibrosis at the 2015 Cystic Fibrosis Foundation Research Conference
Resunab Resolves Lung Inflammation, Reduces Bacterial Load, and Improves Survival in a CFTR-Deficient Mouse Model
NORWOOD, MA -- (Marketwired) -- 06/01/15 -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that positive data on the effects of Resunab™ in the cystic fibrosis ("CF") transmembrane conductance regulator ("CFTR")-deficient mouse model will be presented at the 2015 Cystic Fibrosis Foundation Research Conference: Pushing the Frontiers.
"Resunab Benefits in The Murine Model of CF Lung Infection and Inflammation without Jeopardizing Resolution of Pseudomonas Aeruginosa (PA) Colonization in the Lung," will be presented during the poster sessions being held June 1-2, 2015 in Chantilly, Virginia. The abstract will be presented by Mark A. Tepper, Ph.D., President and Chief Scientific Officer of the Company.
The results of the study indicate that in CFTR-deficient mice infected with Pseudomonas aeruginosa, Resunab improved survival, decreased weight loss, reduced the numbers of neutrophils and white blood cells in the lung and improved the ability of animals to resolve pulmonary infection as assessed by lung bacterial colony forming units ("CFUs"), compared to control treatment. The study suggests that Resunab could potentially be effective in addressing inflammation in cystic fibrosis patients, and furthermore improve the body's ability to resolve pulmonary bacterial infection.
"This study provides additional preclinical confirmation of the potential for Resunab via its novel inflammation-resolving mechanism of action to treat diseases like CF in which chronic inflammation and infection contribute to disease progression," said Dr. Tepper. "As shown in previous preclinical and Phase 1 studies, Resunab was well tolerated and demonstrated a satisfactory safety profile with no evidence of immune suppression. Data showing that Resunab improved overall health in CFTR-deficient mice and reduced bacterial bioburden is encouraging as we prepare to commence our CF Phase 2 clinical study over the next 90 days."
This study was conducted by Tracey L. Bonfield, Ph.D., D(AMBLI), at the Cystic Fibrosis Foundation Anti-Inflammatory Pre-Clinical Modeling Core Center, Pediatrics at Case Western Reserve University in Cleveland, Ohio, in collaboration with Corbus Pharmaceuticals, Inc.
"The results with Resunab in this model are truly encouraging with respect to the potential of Resunab to treat CF through its novel mechanism of inflammatory resolution," said Dr. Bonfield. "I look forward to adding to these studies with additional data on the mechanism of action of Resunab in CF."
About Cystic Fibrosis
CF is a life-threatening, genetic disease that primarily affects the lungs and digestive system. It effects about 30,000 people in the United States (approximately 70,000 worldwide). People with CF inherit a defective CFTR gene that results in reduced chloride transport and a build-up of thick mucus in the lungs, pancreas and other organs. The patients have excessive and ineffective inflammatory responses in their lungs. The thick mucus traps bacteria in the airways resulting in infections and more inflammation. The chronic unresolved lung inflammation can lead to lung damage and scarring (fibrosis) and respiratory failure. Respiratory problems are the most serious and persistent complication for individuals with CF. For more information on cystic fibrosis, go to www.cff.org.
Resunab™ is a novel synthetic oral drug that is a preferential agonist to the CB2 receptor expressed on activated immune cells. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in pre-clinical models of inflammation and fibrosis. Resunab triggers resolution of inflammation by increasing production of "Specialized Pro-resolving Lipid Mediators of Inflammation" and anti-inflammatory mediators, while reducing production of pro-inflammatory mediators and reducing numbers of immune cells in affected tissues. Resunab has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression.
About Corbus Pharmaceuticals
Corbus Pharmaceuticals is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases. Our lead product candidate Resunab™ is a novel oral drug that resolves chronic inflammation and fibrotic processes. Resunab is scheduled to commence Phase 2 clinical trials for the treatment of cystic fibrosis and diffuse cutaneous systemic sclerosis (scleroderma) in 2015. For more information, please visit www.CorbusPharma.com.
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
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Source: Corbus Pharmaceuticals Holdings, Inc.
Released June 1, 2015