Corbus Pharmaceuticals Receives FDA Clearance to Initiate Phase 2 Clinical Study of Resunab for the Treatment of Cystic Fibrosis

Corbus Pharmaceuticals Holdings, Inc. CRBP ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, life-threatening chronic inflammatory and fibrotic diseases, announced today that its Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") is now open and the Company is authorized to initiate a Phase 2 clinical study with Resunab™ for the treatment of cystic fibrosis ("CF"). Corbus expects to initiate a Phase 2 clinical study with Resunab in adults with CF within the next 90 days. CF is a chronic, life-threatening, genetic disease that primarily affects the lungs and digestive system. CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. In the lungs, the abnormal protein causes the buildup of thick, sticky mucus which, in turn, leads to recurrent bacterial infections, chronic inflammation and pulmonary fibrosis. Individuals with CF have an exaggerated, yet ineffective, innate immune response that compounds the inflammation and lung damage caused by the infections. The outcome is relentless, harmful inflammation leading to progressive lung damage and eventual failure impacting both the quality and duration of life. Resunab is a novel synthetic oral drug that has the potential to treat the chronic pulmonary inflammation and fibrosis associated with disease progression in CF, regardless of an individual's specific CFTR gene mutation. Corbus recently received a $5 million development award from Cystic Fibrosis Foundation Therapeutics ("CFFT") to support the Company's Phase 2 clinical trial of Resunab for the treatment of CF. "The CFFT, European Cystic Fibrosis Society, and key investigators provided expert and invaluable advice on the design of our Phase 2 CF study, and we are grateful to them for this assistance. With their help, we are pleased to have achieved this important regulatory milestone for our clinical development program," stated Barbara White, M.D., Chief Medical Officer of the Company. "The existing clinical safety data, as well as the pre-clinical efficacy data, points to the potential for Resunab to provide therapeutic benefit to CF patients. We believe that Resunab could potentially improve the clinical outcome for individuals with CF and favorably impact their lives." "Based on its novel mechanism of action that turns on the resolution of the inflammation pathway, Resunab has the potential to treat the chronic lung inflammation and fibrosis at the root of the morbidity associated with CF," added James Chmiel, M.D., M.P.H., co-principal investigator of the Phase 2 study, specialist in pediatric pulmonary diseases in the Division of Pediatric Pulmonology, Allergy, Immunology and Sleep Medicine and Associate Director of the LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies & Children's Hospital. "I believe Resunab has encouraging potential as a novel therapy for CF and look forward seeing its potentially life-changing outcome for individuals with CF." The Phase 2 clinical trial is a multi-center, international, double-blind, randomized, placebo-control study with multiple doses and will enroll approximately 70 adults with CF. Study participants will each be treated daily for a period of 84 days, with a follow-up period of 28 days. The clinical trial is expected to be completed within 18 to 21 months. It is designed to evaluate Resunab's safety and tolerability, along with its potential impact on clinical outcomes as measured by FEV1, Lung Clearance Index and CFQ-R Respiratory Domain response. In addition, the study will explore multiple exploratory endpoints to determine the impact of Resunab on biomarkers for disease activity, inflammation and lung microbiota. The Company plans to file for Clinical Trial Authorisations in multiple European countries to test Resunab in cystic fibrosis starting in the third quarter of 2015.