Date: 2016-12-29
Type of information: Completion of the trial
phase: 2
Announcement: completion of the trial
Company: Corbus Pharmaceuticals (USA - MA)
Product: Resunab™- JBT-101 - (6aR,10aR)-3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-6H-Dibenzo(b,d)pyran-9-carboxylic acid
Action
mechanism: cannabinoid receptor agonist. Resunab™ is a novel synthetic oral drug that is a preferential agonist to the CB2 receptor expressed on activated immune cells. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in pre-clinical models of inflammation and fibrosis. Resunab™ triggers resolution of inflammation by increasing production of "Specialized Pro-resolving Lipid Mediators of Inflammation" and anti-inflammatory mediators, while reducing production of pro-inflammatory mediators and reducing the numbers of immune cells in affected tissues. Resunab™ has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression. Resunab™- JBT-101 was granted Orphan Drug Designation and Fast Track status for the treatment of cystic fibrosis from the 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 ("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 ("SLE") planned to commence in the first quarter of 2017.
Disease: cystic fibrosis
Therapeutic area: Rare diseases - Genetic diseases
Country: Belgium, France, USA
Trial
details: The Phase 2 clinical trial with Resunab is a double-blind, randomized, placebo-control study with multiple doses that will enroll approximately 70 adults with CF irrespective of their CFTR mutation. Study participants will each be treated daily for a period of 84 days, with a follow-up period of 28 days. The study is expected to be completed within 18 to 21 months and is designed to evaluate Resunab's safety and tolerability, along with its potential impact on clinical outcomes as measured by FEV1, Lung Clearance Index, CFQ-R Respiratory Symptom scale, and lung microbiota. The trial will test the impact of Resunab on biomarkers of inflammation in the sputum and blood. The international, multi-center, double-blinded, randomized, placebo-control trial is supported by a $5 million development award from the Cystic Fibrosis Foundation. (NCT02465450)
Latest
news: * On December 29, 2016, Corbus Pharmaceuticals announced that it has completed its Phase 2 study evaluating JBT-101 (Resunab) for the treatment of cystic 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%, 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. The Company recently reported positive topline data results from its Phase 2 study in diffuse cutaneous systemic sclerosis ("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. * On September 12, 2016, Corbus Pharmaceuticals announced that it has completed subject enrollment in its Phase 2 clinical study of Resunab for the treatment of cystic fibrosis. The Company expects to report top-line results from this study early in the first quarter of 2017. * On October 15, 2015, Corbus Pharmaceuticals announced that the first subject was dosed in the Phase 2 clinical study of Resunab™ for the treatment of cystic fibrosis. The international, multi-center, double-blind, randomized, multi-dose, placebo-control trial is designed to evaluate Resunab's safety and tolerability in up to 70 adults with CF irrespective of their CFTR mutation. Study subjects will be treated with Resunab daily for a period of 84 days, with a follow-up period of 28 days. The impact on clinical outcomes will be measured by FEV1, Lung Clearance Index, CFQ-R Respiratory Symptom scale, and lung microbiota. Additionally, Resunab's impact on biomarkers of inflammation in the sputum and blood will be assessed. The Phase 2 trial in CF is expected to be completed by the end of 2016. * On September 21, 2015, Corbus Pharmaceuticals announced that patient enrollment has commenced in the Phase 2 clinical study of its investigational new drug Resunab™ for the treatment of cystic fibrosis. Resunab™ is a novel oral drug targeting the resolution of inflammation and fibrosis associated with disease progression in cystic fibrosis across all CFTR gene mutations.
In April 2015, Corbus received a $5 million development award from Cystic Fibrosis Foundation Therapeutics, Inc. to support this multi-center, international Phase 2 study of Resunab in CF. The trial, which enrolls adult patients with CF, is being led in the U.S. by principal investigator James Chmiel, M.D., M.P.H., specialist in pediatric pulmonary diseases in the Division of Pediatric Pulmonology, Allergy, Immunology and Sleep Medicine and Associate Director of the LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies & Children's Hospital, and in the EU by co-principal investigator Professor J. Stuart Elborn, M.D., Dean, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Northern Ireland.
