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Corbus Pharmaceuticals Announces Last Subject Enrolled in Phase 2 Study of Resunab for the Treatment of Cystic Fibrosis

NORWOOD, MA--(Marketwired - September 12, 2016) - Corbus Pharmaceuticals Holdings, Inc. (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...