Corbus Pharma (CRBP) Reports Last Subject Enrolled in Phase 2 Study of Resunab in CF
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Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today that it has completed subject enrollment in its Phase 2 clinical study of Resunab for the treatment of cystic fibrosis ("CF"). The Company expects to report top-line results from this study early in the first quarter of 2017. The international, multi-center, double-blinded, randomized, placebo-control trial is supported by a $5 million development award from the Cystic Fibrosis Foundation.
The objectives of the study are to evaluate Resunab's safety, tolerability and efficacy in adults with CF, without regard to underlying genetic mutation or infecting pathogen. Study subjects are being treated with Resunab daily for a period of 84 days, with a follow-up period of 28 days. Efficacy outcomes include lung function as measured by forced expiratory volume in 1 second (FEV1) and patient-reported symptoms. Additionally, Resunab's impact on sputum microbiota and biomarkers of inflammation in sputum and blood will be assessed.
"Resunab's intended pharmacological activity is resolution of chronically activated innate immune responses including tissue inflammation and fibrosis. This novel mechanism of action is expected to reduce airway obstruction and, ultimately, lung destruction over time in CF," stated Barbara White, M.D., Chief Medical Officerof the Company.
James Chmiel, M.D., M.P.H. is Professor of Pediatrics, Case Western Reserve University, Associate Director of the LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies and Children's Hospital in Cleveland, and principal investigator for the trial in the United States. Dr. Chmiel commented, "Inflammation causes lung damage in CF, and none of the approved treatments for CF directly address this aspect of the disease. By activating the resolution phase of inflammation, Resunab has the potential to provide a clinical benefit not being offered by the current medications for CF."
Yuval Cohen, Ph.D., Chief Executive Officer of the Company, commented, "We are pleased to have achieved this important clinical milestone for Resunab and will complete this trial before year's end, with top-line data readout expected early in the first quarter of 2017. We are grateful to the individuals and physicians who have participated in the study and to the Cystic Fibrosis Foundation for its support."
Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of CF from the U.S. Food and Drug Administration ("FDA") in 2015. Resunab is currently being evaluated in three separate Phase 2 clinical studies in CF, diffuse cutaneous systemic sclerosis ("systemic sclerosis"), and skin-predominant dermatomyositis. Top-line data from the systemic sclerosis study is expected to be reported in the fourth quarter of 2016, for the CF study in the first quarter of 2017, and for dermatomyositis study in the second half of 2017. A clinical study of Resunab in the treatment of systemic lupus erythematosus ("SLE") is planned for the first half of 2017.
For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT02465450.
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