Corbus Pharmaceuticals Gains FDA Orphan Drug Designation for Resunab™ for the Treatment of Systemic Sclerosis

Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) announced that the FDA has granted its lead drug candidate Resunab™ Orphan Drug Designation for the treatment of systemic sclerosis.

As quoted in the press release:

Resunab is a novel synthetic oral drug that has the potential to treat chronic inflammation and fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. The FDA has already cleared the Corbus’ investigational new drug application (“IND”) for systemic sclerosis and the Company is preparing to commence Phase 2 studies.

Systemic sclerosis is a chronic, serious, life-threatening inflammatory disease causing fibrosis of skin and internal organs, affecting predominately women in mid-life. Systemic sclerosis is associated with severe morbidity and high mortality. There are currently no FDA-approved drug therapies for systemic sclerosis.

The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.

Yuval Cohen, PhD, CEO of Corbus Pharmaceuticals, commented:

We are very pleased to receive FDA Orphan Drug Designation for Resunab in systemic sclerosis. This is an important regulatory milestone for the company and a significant step forward in our clinical development of Resunab targeting this rare disease associated with such a critical unmet need for safe and effective therapeutics. Based on its novel mechanism of action of triggering the inflammatory resolution pathway, we believe Resunab has the potential to become an important therapy for systemic sclerosis patients as well as other diseases in which chronic inflammation and fibrosis persist.

Click here to read the full Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) press release.