Resunab is a new synthetic oral endocannabinoid-mimic drug that preferentially binds to a receptor called CB2 on immune cells and fibroblasts.
According to several pre-clinical and ex-vivo models, binding of Resunab to CB2 triggers the production of specialized pro-resolving lipid mediators (SPMs) that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis.
Systemic sclerosis is characterized by chronic activation of the immune system, damage to blood vessels, and fibrosis (scarring) of the skin, lungs, and other internal organs.
The disease affects predominately women in mid-life and is associated with significant morbidity and mortality, and currently there are no FDA-approved drug therapies.
Corbus chief executive officer Yuval Cohen 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."
The company intends to start enrollment and dosing in its Phase II trial of Resunab this quarter.