FDA approves Corbus’ IND to begin Phase II trial of Resunab to treat scleroderma

Scleroderma causes fibrosis of skin, joints and internal organs and predominately affects women in mid-life.

Resunab is a new, oral specialized pro-resolving mediator drug and it binds to the CB2 receptor on immune cells and triggers a process known as inflammatory resolution, in effect turning chronic inflammation off.

Corbus Pharmaceuticals chief medical officer Barbara White said: "This IND clearance enables us to proceed with our Phase II study in scleroderma and represents a major step forward in our clinical development strategy for Resunab.

"We look forward to working with our clinical investigators to advance Resunab in this Phase 2 study aimed at establishing safety in this patient population and modifying the outcome of this disease.

"Based on its novel mechanism of activating the inflammatory resolution pathway, Resunab has the potential to become an important therapy for scleroderma patients as well as for potentially other diseases in which chronic inflammation and fibrosis are present."

The double-blind, randomized, placebo-control Phase II trial with multiple doses will be conducted at several centers in the US and is expected to take 18 months to complete.

Around 36 patients with scleroderma will be enrolled in the trial and they will each be treated daily for a period of three months with a follow-up period of one month.

The trial, scheduled to begin in the second quarter of 2015, is designed to evaluate Resunab’s safety and tolerability, along with its potential impact on clinical outcomes as measured by the combined response index for systemic sclerosis or CRISS score.

Additionally, the trial will explore multiple secondary endpoints to better determine changes in the patients’ inflammatory status.

The company is also planning to submit a Phase II protocol under this open IND for the treatment of cystic fibrosis in the second quarter of 2015.