Corbus Pharmaceuticals, a clinical stage company targeting rare, chronic inflammatory and fibrotic diseases, recently received approval by the U.S. Food and Drug Administration (FDA) for a 12-month open-label extension trial of the ongoing Phase 2 study testing Resunab as a therapy for diffuse cutaneous systemic sclerosis.
Resunab was granted FDA Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis in 2015. Afterward, Corbus launched its multi-center, double-blind, randomized, placebo-controlled Phase 2 trial to assess Resunab’s safety and tolerability in up to 36 patients with systemic sclerosis.
The open label extension study will give the participants in the Phase 2 study, whether they were in the control (placebo) or experimental group, the option of receiving Resunab treatment following the completion of the 84-day ongoing trial. The goal is to collect long-term safety and efficacy data on Resunab.
“There is a clear unmet need for effective therapy options for individuals living with systemic sclerosis,” said the principal investigator of the study, Dr. Robert Spiera, M.D., director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City, in a press release. “Since the launch of the study, individuals have been very receptive to participating, and we look forward to furthering our understanding of the long-term safety and efficacy of Resunab through this open-label extension study.”
Spiera’s colleague, Dr. Barbara White, M.D., chief medical officer of Corbus, agreed. “We are delighted to be able to offer the patients in our systemic sclerosis trial the opportunity to continue in a 12-month, open-label extension study of Resunab, upon their completion of the blinded portion of the trial. The additional 12 months of safety and efficacy data will be invaluable to the clinical advancement of this promising drug,” White said.
“This is a noteworthy clinical milestone for Corbus, and we would like to express our gratitude to the subjects and the clinical study teams participating in the study. We are grateful for the opportunity to further the clinical development of Resunab,” said Corbus CEO Yuval Cohen, Ph.D.
For more information on the Phase 2 clinical trial (identifier NCT02465437) assessing Resunab for the treatment of systemic sclerosis, visit this link.