Clinical stage pharmaceutical company Corbus Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application allowing the company to begin a phase 2 clinical study to evaluate its treatment for diffuse cutaneous systemic sclerosis called Resunab.
The phase 2 clinical trial is targeted to commence during the second quarter of this year and is designed as a double-blind, randomized, placebo-controlled study. The trial will include 36 scleroderma patients who will be treated with either Resunab or given a placebo each day for three months in several study centers throughout the United States. The patients will be followed for one month after treatment.
“This IND clearance enables us to proceed with our Phase 2 study in scleroderma and represents a major step forward in our clinical development strategy for Resunab,” said the chief medical officer of Corbus, Barbara White, MD. “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,” continued White.
The clinical study, which is expected to last a total of 18 months, will assess the safety and tolerability profile of Resunab and its efficacy in treating the disease. The clinical outcomes will be evaluated according to the combined response index for systemic sclerosis, the CRISS score. The investigators will also analyze numerous secondary endpoints in order to understand alterations in the inflammatory status of the patients.
“I am looking forward to investigating Resunab’s potential to address such an important unmet medical need for the estimated 50,000 adults with scleroderma in the U.S. who could benefit from a potentially safe and effective treatment option for their severe, progressive and currently untreatable fibrosis,” said the lead investigator in the study, Robert Spiera, MD, who is the director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery in New York City.
In addition, Corbus also plans to submit a phase 2 protocol for Resunab to treat cystic fibrosis (CF) under the open IND during the second quarter of the year. “Moving forward, we look forward to the initiation of this clinical trial in scleroderma and submitting our Phase 2 clinical protocol to the FDA for the treatment of cystic fibrosis with Resunab,” added White.
Scleroderma particularly affects middle aged women and causes fibrosis of the skin, joints and internal organs. Since there is a high a morbidity and mortality associated with the disease and there is currently no treatment approved for it, Corbus is dedicated to offering a new option for scleroderma patients. Given the promising results of the drug development process for Resunab so far, the company has recently presented it at VirtualInvestorConferences.com, a live, interactive, online event that gathers companies and investors.