April 5 Corbus Pharmaceuticals said on Wednesday that the U.S. health regulator only requires one positive pivotal late-stage study to support a marketing application for its lead experimental therapy as a treatment for scleroderma.
The drug, anabasum, which is designed to bind to the CB2 receptor found on immune cells, aims to mimic a natural process to "turn off" chronic inflammation and scarring, without causing immuno-suppression. It is being evaluated for use in many inflammatory conditions, including cystic fibrosis and lupus.
The 270-patient late-stage scleroderma study is expected to begin in the fourth quarter, with data expected in 2019, Corbus said, adding that it was also engaging in similar discussions with the European regulator. (Reporting by Natalie Grover in Bengaluru; Editing by Martina D'Couto)
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