Corbus Pharmaceuticals Holdings, Inc. announced that the European Commission has granted Orphan Designation in the European Union for the company's novel synthetic oral endocannabinoid-mimetic drug, JBT-101 ("Resunab") for the treatment of systemic sclerosis. The company previously announced that JBT-101 was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis and cystic fibrosis by the U.S. Food and Drug Administration and Orphan Designation for the treatment of CF in the EU. The company reported positive topline data from its Phase 2 study of JBT-101 for the treatment of systemic sclerosis in November 2016. The results of the Phase 2 study showed that JBT-101 improved the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching a median of 33% at week 16 in the JBT-101 treated group versus 1% for placebo. Changes from baseline in the five individual domains of the CRISS score also supported clinical benefit of JBT-101. JBT-101 is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the cannabinoid receptor type 2 (CB2) expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and Phase 1 studies have shown JBT-101 to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in preclinical models of inflammation and fibrosis. JBT-101 is designed to trigger the production of 'Specialized Pro-resolving Lipid Mediators' that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators. JBT-101 has direct effects on fibroblasts to halt tissue scarring. In effect, JBT-101 triggers endogenous pathways to turn 'off' chronic inflammation and fibrotic processes, without causing immunosuppression.