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Corbus Pharmaceuticals Announces Agreement with FDA on Phase 2b Cystic Fibrosis Study Design
Jan. 31, 2018 08:29AM PST
Pharmaceutical InvestingCorbus Pharmaceuticals (NASDAQ: CRBP) a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration regarding the design of its next study of lenabasum (formerly known as anabasum), a novel, oral, pro-resolving drug, in the treatment of cystic fibrosis. …
Corbus Pharmaceuticals (NASDAQ: CRBP) a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration regarding the design of its next study of lenabasum (formerly known as anabasum), a novel, oral, pro-resolving drug, in the treatment of cystic fibrosis.
As quoted in the press release
The Phase 2b multicenter, double-blinded, randomized, placebo-controlled study will enroll approximately 415 subjects with CF who are at least 12 years of age and at increased risk for pulmonary exacerbations. Secondary efficacy outcomes include other measures of pulmonary exacerbations, change in Cystic Fibrosis Questionnaire-Revised Respiratory domain score and change in forced expiratory volume in 1 second (FEV1), % predicted.
