Corbus Pharmaceuticals Holdings, Inc., a clinical stage drug development company focused on addressing rare, chronic, and serious inflammatory and fibrotic diseases, recently announced that the US Food and Drug Administration has granted its orally-available CB2 receptor agonist Resunab Fast Track Development status for systemic sclerosis. With the FDA’s Fast Track Designation, Corbus will be entitled to more frequent meetings with the agency, which will help accelerate Resunab’s development and review.
Scleroderma has often been associated with a higher risk of pulmonary arterial hypertension (PAH) in previous research. This is because in patients with scleroderma, there is progressive blood vessel contraction (narrowing) that often leads to an increase in blood pressure in the lungs, which can in turn develop into PAH.
Resunab is an innovative synthetic endocannabinoid-mimic that works by selectively binding to CB2 receptors located on immune cells and fibroblasts. Several pre-clinical and ex vivo models of systemic sclerosis have exhibited the drug’s ability to stimulate production of Specialized Pro-resolving Lipid Mediators or SPMs, which play a major role in regulating the body’s natural inflammatory and fibrotic processes. The resolution of this endogenous cascade results in the immune system’s return to a homeostatic state and a stop in fibrotic activity, without compromising the whole immune system.
“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,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “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.”
Corbus is scheduled to begin enrollment and dosing in its Phase 2 study of Resunab for the treatment of systemic sclerosis this quarter.