Corbus Pharmaceuticals Holdings, Inc., a clinical-stage drug development firm committed to addressing chronic, rare and serious inflammatory and fibrotic diseases, recently announced that the United States Food and Drug Administration (FDA) has awarded the Fast Track development program designation to the company’s Resunab™’s project for systemic sclerosis (scleroderma).

Systemic sclerosis is a life-threatening autoimmune disease characterized by the chronic activation of the immune system, scarring of the skin, damage to blood vessels, lungs, and internal organs. The disease affects mostly women in mid-life and is linked to higher mortality and morbidity. Currently, there are no FDA-approved drugs to treat systemic sclerosis.

Resunab is a synthetic oral drug that mimics endocannabinoid and binds to the CB2 receptor on immune cells and fibroblasts. Pre-clinical and ex-vivo models have shown that when Resunab and CB2 are bound, the production of “Specialized Pro-resolving Lipid Mediators” (“SPMs”) triggers an endogenous cascade that positively impacts inflammation and fibrosis, restoring homeostasis without the need for immunosuppression.

Yuval Cohen, Corbus’ Chief Executive Officer, said: “We are very pleased to have achieved another significant regulatory milestone for Resunab for the treatment of systemic sclerosis, following the recently granted FDA Orphan Drug Designation in this indication. With Fast Track status, we expect to have the opportunity to accelerate Resunab’s clinical development timeline to more expediently bring this potentially impactful drug therapy to individuals with systemic sclerosis.”

Thanks to the Fast Track designation, the FDA approval process can be accelerated in order to accelerate approval in order to offer treatments for life-threatening diseases like SSc.

Corbus intends to begin patient enrollment and dosing for Resunab’s Phase 2 trial on systemic sclerosis.

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