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Resunab granted fast track status by FDA for scleroderma studies
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Corbus Pharmaceuticals announced Resunab has been granted fast track status by the FDA to investigate the treatment of scleroderma, according to a company press release.
Resunab (JBT-101, Corbus Pharmaceuticals) is a synthetic, oral, preferential agonist to the CB2 receptor that is expressed on immune cells to resolve inflammation without immunosuppression. According to the release, the drug increases the production of “specialized pro-resolving lipid mediators of inflammation.”
Fast track status allows for expedited review and communication with the FDA about the investigation. Enrollment into a phase 2 study of patients with scleroderma is scheduled to begin during this quarter.
“We are very pleased to have achieved another significant regulatory milestone for Resunab for the treatment of systemic sclerosis, following the recently granted FDA orphan drug designation in this indication,” Yuval Cohen, PhD, chief executive officer of Corbus, said in the release. “With fast track status, we expect to have the opportunity to accelerate Resunab's clinical development timeline to more expediently bring this potentially impactful drug therapy to individuals with systemic sclerosis.”
A phase 2 trial is also planned this year for the treatment of cystic fibrosis and is currently being studied in phase 2 for the treatment of diffuse, cutaneous systemic sclerosis and dermatomyositis.
Reference: www.corbuspharma.com.