Corbus Pharmaceuticals Holdings Inc. announced that a protocol amendment has been added to one of the Company's existing Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration ("FDA") for a Phase 2 clinical trial of Resunab in systemic lupus erythematosus ("SLE").
The amendment was filed on February 25, 2016. The addition of the SLE Phase 2 trial to the existing Resunab IND is an important step towards the initiation of the 100 patient, double-blind, placebo-controlled SLE trial which will be funded by a grant from the National Institutes of Health ("NIH") to the Feinstein Institute for Medical Research ("FIMR"), Manhasset. The Company expects the trial will commence in the first quarter of 2017.
Resunab is a novel synthetic endocannabinoid-mimetic drug that we believe has the potential to resolve widespread inflammation associated with active SLE, and, in particular, inflammation of the musculoskeletal system.
The Phase 2 SLE trial will evaluate Resunab at 5 mg, 20 mg, and 20 mg twice daily, administered orally for 84 days, with 28 days follow-up, at approximately ten U.S. sites. The primary outcome assesses pain from active musculoskeletal disease and secondary efficacy outcomes include assessments of overall disease activity using standard SLE Disease Activity Index ("SLEDAI") and British Isles Lupus Activity Group ("BILAG") scoring systems in SLE. Resunab is currently being evaluated in three on-going Phase 2 clinical trials for the treatment of cystic fibrosis, systemic sclerosis, and dermatomyositis.
