- Topline data on schedule for Q3 2020
- Reduction in pulmonary exacerbations (PEx) as primary endpoint
- Study enrolled 426 participants regardless of CFTR mutation or background CFTR-targeting therapies
- Treatment of inflammation to reduce PEx remains a key unmet need in CF
- Study is funded in part by a Development Award for up to $25 Million from the Cystic Fibrosis Foundation
Norwood, MA, June 22, 2020 (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 that the last subject completed their final visit in the Company's Phase 2b JBT101-CF-002 trial of lenabasum for the treatment of cystic fibrosis. Topline results from the study are on track to readout in the third quarter of 2020, following the topline data from the RESOLVE-1 Phase 3 systemic sclerosis study.
"Thank you to the clinical investigators and their staff, the people with CF in the study, and our team for their commitment and determination to complete the study on time even in the midst of a global pandemic," said Yuval Cohen, Ph.D, Chief Executive Officer. "We thank the Cystic Fibrosis Foundation for providing disease expertise and financial support to facilitate the design and execution of this study."
The Phase 2b trial is a multinational, 426-subject study evaluating the efficacy and safety of lenabasum in cystic fibrosis. This is a double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 5 mg twice per day, lenabasum 20 mg twice per day or placebo twice per day for 28 weeks, with 4 weeks safety follow-up off active treatment.
The primary efficacy endpoint is the event rate of pulmonary exacerbation (PEx). Secondary efficacy outcomes include other measures of PEx, 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 has been granted Orphan Drug designation and Fast Track designation for the treatment of cystic fibrosis by the U.S. Food and Drug Administration (FDA) and Orphan Designation for the treatment of cystic fibrosis from the European Medicines Agency (EMA).