Corbus Pharmaceuticals Receives Orphan Designation for Resunab for the Treatment of Cystic Fibrosis in the European Union
NORWOOD, MA--( October 18, 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 the European Commission has granted Orphan Designation in the European Union for the Company's novel synthetic oral endocannabinoid-mimetic drug, Resunab, for the treatment of cystic fibrosis ("CF").
The Company previously announced that Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of CF and the treatment of systemic sclerosis in the U.S. by the Food and Drug Administration ("FDA"). Resunab is currently being evaluated in three Phase 2 trials in CF, systemic sclerosis, and dermatomyositis, respectively. A fourth National Institutes of Health-sponsored clinical study of Resunab insystemic lupus erythematosus is planned to begin in the first quarter of 2017.
"Receiving Orphan Designation for Resunab in the treatment of CF in the European Union is a noteworthy milestone in our global regulatory strategy for the clinical development of Resunab in CF," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.
- Published: 19 October 2016
- Written by Editor