Corbus Pharmaceuticals Holdings, Inc., a clinical stage drug advancement company focused on addressing chronic rare and serious fibrotic inflammatory diseases, announced recently that the United States Food and Drug Administration (FDA) has granted Corbus’ lead candidate Resunab Orphan Drug Designation to treat systemic sclerosis.

Systemic sclerosis is a life-threatening condition that causes fibrosis of skin and of the internal organs. Systemic sclerosis has high mortality rates and there are no FDA-approved drugs to treat the disease. SSc affects about 70,000 Americans, 80% of which are women in mid-life, and about 4 or 5 of every 10 patients in the U.S. diagnosed with the disease die within 10 years of diagnosis. Corticosteroids are frequently used as immunosuppressive medications to treat these individuals, however, there are still unmet medical needs.

“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,” said Yuval Cohen, Corbus’ CEO. The FDA provides an Orphan Drug Designation to drugs that aim to address orphan diseases that strike less than 200,000 people in the United States which ensures a 7-year marketing exclusivity period and other credits.

Resunab, a synthetic oral drug, is a preferential agonist to the CB2 receptor that is expressed on activated immune cells. When CB2 is activated, endogenous pathways are turned on to address inflammation. Resunab helps to solve inflammation through increasing the production of anti-inflammatory mediators and “Specialized Pro-resolving Lipid Mediators of Inflammation,” reducing the amount of pro-inflammatory mediators and by turning “off” fibrotic and chronic inflammation processes, without implying immunosuppression.

Corbus reports that pre-clinical and Phase 1 studies for Resunab revealed favorable pharmacokinetic, tolerability and safety profiles. Phase 2 studies for the experimental therapy are slated to start soon, according to the company.