Corbus Pharmaceuticals announced the addition of a protocol amendment to one of the company’s existing Investigational New Drug (IND) Applications with the FDA for a Phase 2 clinical trial of Resunab for the treatment of systemic lupus erythematosus (SLE), an important step to initiate a multicenter placebo-controlled SLE trial. The clinical study, expected to begin early in 2017, will be funded by a grant from the National Institutes of Health (NIH) to the Feinstein Institute for Medical Research (FIMR), Manhasset.
Resunab is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. The activation of this receptor triggers endogeneous pathways that result in normalization of inflammation and fibrosis. Pre-clinical and Phase 1 studies have showed the drug has a favorable safety, tolerability, and pharmacokinetic profile, demonstrating promising potency in pre-clinical models of inflammation and fibrosis without causing immunosuppression. The drug is currently being evaluated in three on-going Phase 2 clinical trials for the treatment of cystic fibrosis, systemic sclerosis, and dermatomyositis.
The Phase 2 clinical trial will assess the efficacy of Resunab, administered orally for 84 days and with a 28-day follow-up, at 5 mg, 20 mg, and 20 mg twice daily, at 10 U.S. clinical sites. The primary outcome consists in the assessment of pain derived 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.
“Corticosteroids or other immunosuppressive therapies are commonly used by physicians to treat patients with SLE who have active musculoskeletal disease that is refractory to anti-malarial agents and NSAIDS. Because these treatments can have major toxicities, there remains a significant unmet medical need in the treatment of SLE. I believe Resunab has the potential to treat active musculoskeletal disease and overall disease activity in SLE,” principal investigator of the study, Dr. Meggan Mackay, M.D., M.S., said in a press release.