Corbus Pharmaceuticals completes enrollment of Phase 2b study of lenabasum
Corbus Pharmaceuticals Holdings announced the completion of patient enrollment in the Phase 2b study evaluating the efficacy and safety of lenabasum for the treatment of cystic fibrosis. The Company expects to report topline data from this study in the summer of 2020. Lenabasum has Orphan Drug Designation and Fast Track status for treatment of CF. Corbus has enrolled 426 individuals with CF in the Phase 2b international, multicenter, randomized, double-blind, placebo-controlled study that is being conducted in North America, Europe, and Israel. Patients in the study are randomized 1:2:2 to either receive lenabasum 5 mg twice per day, lenabasum 20 mg twice per day or placebo twice per day for 28 weeks, with 4 weeks follow-up off active treatment. The primary efficacy endpoint of the Phase 2b CF study is the event rate of pulmonary exacerbation. Secondary efficacy outcomes include other measures of pulmonary exacerbations, change in forced expiratory volume in 1 second, % predicted, and change in Cystic Fibrosis Questionnaire-Revised respiratory domain score. The Phase 2b CF study is funded in part by a Development Award for up to $25M from the Cystic Fibrosis Foundation. Lenabasum was granted Orphan Drug Designation for the treatment of CF by the FDA, Orphan Designation by the European Medicines Agency and granted Fast Track status by the FDA. Lenabasum is not approved for the treatment of cystic fibrosis.