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news.The US Food and Drug Administration (FDA) has granted orphan drug designation for Corbus Pharmaceuticals' lead drug candidate Resunab for the treatment of systemic sclerosis, a chronic, serious, life-threatening inflammatory disease.
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Resunab is a new synthetic oral drug that has the potential to treat chronic inflammation and fibrosis.
Systemic sclerosis causes fibrosis of skin and internal organs, affecting predominately women in mid-life and it is associated with severe morbidity and high mortality.
Currently, there are no FDA-approved drug therapies for systemic sclerosis.
Corbus Pharmaceuticals chief executive officer Yuval Cohen said: "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."
Pre-clinical and Phase I trials have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile.
The FDA has already cleared the company’s investigational new drug application (IND) for systemic sclerosis.
Currently, the company is preparing to initiate Phase II trials of Resunab, which is a preferential agonist to the CB2 receptor expressed on activated immune cells.