Date: 2016-11-29
Type of information: Initiation of the trial
phase: 2
Announcement:
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: dermatomyositis
Therapeutic area: Dermatological diseases - Inflammatory diseases
Country: USA
Trial
details: The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine. (NCT02466243)
Latest
news: * On November 29, 2016, Corbus Pharmaceuticals announced that it is commencing a one-year, open-label extension study of the ongoing Phase 2 clinical study of Resunab ("JBT-101") for the treatment of skin-predominant dermatomyositis. This open-label extension was submitted to and reviewed by the FDA. The goal of the open-label extension dermatomyositis study is to provide all enrolled subjects with the option of receiving JBT-101 for one year after they complete the four-month, double-blind placebo controlled portion of the study and to collect long-term safety and efficacy on JBT-101. The safety and efficacy endpoints used in the double-blinded, placebo-controlled portion of the study will be assessed throughout the one year extension study. The Phase 2 study in skin-predominant dermatomyositis is funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health to the University of Pennsylvania School of Medicine.
