Date: 2015-08-19
Type of information: Granting of a Fast Track status
Product name: Resunab™
Compound: (6aR,10aR)-3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-6H-Dibenzo(b,d)pyran-9-carboxylic acid
Therapeutic area: Autoimmune diseases - Rare diseases
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.
Company: Corbus Pharmaceuticals (USA - MA)
Disease: systemic sclerosis (scleroderma)
Latest news: * On August 19, 2015, Corbus Pharmaceuticals, a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced that the FDA has designated as a Fast Track development program the investigation of Resunab™ for systemic sclerosis (scleroderma). Corbus is scheduled to begin enrollment and dosing in its Phase 2 study of Resunab™ for the treatment of systemic sclerosis this quarter (NCT02465437). * On June 10, 2015, the FDA has granted orphan drug designation for (6aR,10aR)-3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-6H-Dibenzo(b,d)pyran-9-carboxylic acid (Resunab™) for the treatment of systemic sclerosis. Resunab™ is a novel synthetic oral drug that has the potential to treat chronic inflammation and fibrosis. Pre-clinical and Phase 1 studies have shown Resunab™ to have a favorable safety, tolerability and pharmacokinetic profile. The FDA has already cleared the Corbus' investigational new drug application for systemic sclerosis and the Company is preparing to commence Phase 2 studies.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2015-06-10
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
