|Corbus Pharma’s Investigational Drug Resunab given fast track status by FDA for the Treatment of Systemic Sclerosis|
|By David Fowler|
|Thursday, 20 August 2015 14:50|
Clinical stage drug development firm Corbus Pharmaceuticals Holdings Inc(NASDAQ:CRBP) has confirmed that U.S. Food and Drug Administration has given Fast Track development program the investigation of Resunab for systemic sclerosis.
This is a life threatening disease which happens due to chronic activation of immune system as well as damage to blood vessels besides other internal organs.
Systemic sclerosis impacts mainly women in in mid-life and is concerned with mortality. Presently, there are no FDA-approved drug therapies for systemic sclerosis.
Resunab is a unique oral endocannabinoid-mimic drug which binds to receptor named CB2 on immune cells and fibroblasts.
Many pre-clinical as well as ex-vivo models showed that binding of Resunab to CB2 leads to production of "Specialized Pro-resolving Lipid Mediators" ("SPMs") which start an endogenous cascade causing resolution of inflammation and fibrosis.
This solution leads to chronically activated immune systems back to homeostasis along with stopping fibrosis.
Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, opined that the firm is glad on having done another major regulatory milestone for Resunab for treating systemic sclerosis. He added that the Fast Track status would provide a chance to expedite Resunab's clinical development timeline to further bring the potentially impactful drug therapy for individuals with systemic sclerosis.
A Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
Corbus is scheduled to begin enrollment and dosing in its Phase 2 study of Resunab for the treatment of systemic sclerosis this quarter. For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT02465437.