Corbus Pharmaceuticals announces completion of Phase 2 study of JBT-101 (Resunab) for the treatment of cystic fibrosis.
Corbus Pharmaceuticals Holdings, Inc., a clinical stage drugdevelopment company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced that it has completed its Phase 2 study evaluating JBT-101 (Resunab) for the treatment of cystic fibrosis (CF). JBT-101, the company’s novel synthetic oral endocannabinoid-mimetic drug, is designed to resolve chronic inflammation and halt fibrosis. Corbus expects to report topline data from this study in the first quarter of 2017.
The international, multi-center, double-blinded, randomized, placebo-controlled Phase 2 study is supported by a $5 million development award from Cystic Fibrosis Foundation Therapeutics, Inc. The primary objective of the study was to test safety and tolerability of JBT-101 in adults with CF who had forced expiratory volume in 1 second (FEV1) percent predicted at least 40 percent, without regard to their CFTR mutation, infecting pathogen, or baseline treatment.
Secondary objectives were to evaluate changes in pro-inflammatory and pro-resolving lipid mediators as a marker of mechanism of action of JBT-101 and to evaluate efficacy with FEV1 and Cystic Fibrosis Questionnaire Revised — Respiratory Symptom Score. Exploratory outcomes included effects of JBT-101 on biomarkers of inflammation and the sputum microbiome. Eighty-five subjects on stable standard-of-care medications were dosed with study product at 21 CF centers in the U.S. and Europe and treated with study product daily for a period of 84 days, with a follow-up period of 28 days.
JBT-101 was granted Orphan Drug Designation and Fast Track status for the treatment of CF from the U.S. Food and Drug Administration (FDA) in 2015 and was granted Orphan Drug Designation by the European Union for the treatment of CF in October 2016. The company recently reported positive topline data results from its Phase 2 study in diffuse cutaneous systemic sclerosis, showing clear signal of clinical benefit with JBT-101.
Additionally, JBT-101 is being evaluated in a Phase 2, 12-month open label extension study in systemic sclerosis, a Phase 2 study in skin-predominant dermatomyositis, with a 12-month open label extension study in dermatomyositis and a another Phase 2 study in systemic lupus erythematosus planned to commence in the first quarter of 2017.
For more information on the Phase 2 study for the treatment of CF, visit ClinicalTrials.gov and reference Identifier NCT02465450.
Filed Under: Drug Discovery