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Corbus Pharmaceuticals Completes Enrollment of Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis
Company expects to report topline data from study in the summer of 2020Primary endpoint of this study is reduction in pulmonary exacerbationsStudy enrolled
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Company expects to report topline data from study in the summer of 2020Primary endpoint of this study is reduction in pulmonary exacerbationsStudy enrolled participants regardless of CFTR mutation Stable background use of CFTR therapies was permittedMilestone advances Corbus’ vision to pioneer the development of transformative medicines that target the endocannabinoid system Norwood, MA, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today announced the completion of patient enrollment in the Phase 2b study evaluating the efficacy and safety of lenabasum for the treatment of cystic fibrosis (CF). 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.\n “We would like to take this opportunity to thank the participants in the study as well as the investigators and their staff,” said Barbara White, M.D., Chief Medical Officer of Corbus. “Lenabasum represents a potential new anti-inflammatory treatment option for people with CF and recurring pulmonary exacerbations. Its potential benefit is without regard to CFTR mutation or the current treatment the patient is receiving. We look forward to announcing topline data from this study in the summer of 2020.” 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 (FEV1), % 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 $25 Million from the Cystic Fibrosis Foundation. Lenabasum was granted Orphan Drug Designation for the ...