Corbus Pharmaceuticals Holdings has received fast track status from the US Food and Drug Administration (FDA) for its investigational drug Resunab to treat systemic sclerosis (scleroderma).
Resunab is a novel synthetic oral drug and preferential agonist to the CB2 receptor expressed on activated immune cells.
Systemic sclerosis is a serious and life-threatening autoimmune disease, which is characterised by chronic activation of the immune system, damage to blood vessels, and fibrosis of the skin, lungs, and other internal organs.
CB2 activation is said to trigger endogenous pathways that resolve inflammation and halt fibrosis.
Corbus Pharmaceuticals Holdings CEO Dr 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.”
In this quarter, the company plans to start enrolment and dosing in its Phase II trial of Resunab for the treatment of systemic sclerosis.
The drug’s pre-clinical and Phase I studies demonstrated favourable safety, tolerability and pharmacokinetic profile. It also showed promising potency in pre-clinical models of inflammation and fibrosis.
Image: Clinical Appearance of Acrosclerotic Piece-meal Necrosis of the Thumb in a Patient with Systemic Sclerosis. Photo: courtesy of Frank Breuckmann, Thilo Gambichler, Peter Altmeyer and Alexander Kreuter.
