Corbus Pharmaceuticals Expands Clinical Development of Resunab(TM) With Phase 2 Trial for the Treatment of Systemic Lupus Erythematosus

National Institutes of Health (NIH) to Fund Multicenter Phase 2 SLE Trial

NORWOOD, MA -- (Marketwired) -- 03/07/16 -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that Resunab™ will be tested for efficacy and safety in a Phase 2 clinical study in systemic lupus erythematosus (SLE). SLE is a prototypic autoimmune disease that can manifest with wide-ranging symptoms involving multiple organ systems.

The SLE trial has been selected for funding by the NIH Autoimmunity Centers of Excellence (ACE) program, through a grant to the Feinstein Institute for Medical Research (FIMR), Manhasset, NY. Cynthia Aranow M.D. is Principal Investigator on the grant, and Meggan Mackay M.D., M.S. is Principal Investigator for the clinical trial of Resunab in SLE. Both Drs. Aranow and Mackay are Investigators at the Center for Autoimmunity & Musculoskeletal Disease at FIMR and Associate Professors of Molecular Medicine at Hofstra Northwell School of Medicine.

Yuval Cohen, Ph.D., Chief Executive Officer of Corbus stated, "We are delighted to have the opportunity to test Resunab in SLE and are grateful for the support that the NIH ACE's program will provide to FIMR to make this possible. We are pleased to expand clinical testing of Resunab into another serious immune-mediated disease with significant unmet medical need."

The Phase 2 trial will test the efficacy, safety, tolerability and biologic effects of Resunab as a novel, non-immunosuppressive oral treatment to improve signs and symptoms of SLE. The study plans to enroll 100 adult SLE patients with active musculoskeletal disease and will be carried out at approximately 10 sites in the United States. These patients will receive either placebo or three different doses of Resunab daily for 84 days with 28 days follow-up.

Meggan Mackay, M.D., M.S., Principal Investigator for the trial, added, "The musculoskeletal system is the most commonly involved system in our patients that causes significant daily pain related to inflammation. After five years of disease, joint involvement affects about 85% of SLE patients. Patients with SLE have limited options for treatment of active disease with non-immunosuppressive drugs. We look forward to testing Resunab for treatment of active musculoskeletal disease and overall disease activity in SLE."

About Systemic Lupus Erythematosus
Systemic lupus erythematosus is a prototypical autoimmune disease with a wide array of clinical manifestations, including arthritis, rash, photosensitivity, oral ulcers, pleuritis, pericarditis, kidney problems, seizures and psychosis and blood cell abnormalities. The musculoskeletal system is the most commonly involved system in SLE. The pathology of SLE involves chronic activation of the innate immune system by immune complexes, with activation of complement, increased production of type 1 interferons and other mediators of inflammation and resultant tissue inflammation and damage. Patients with SLE have an increased frequency of related autoimmune problems, such as Sjogren's syndrome and antiphospholipid syndrome that require additional treatments. SLE may occur with other autoimmune conditions, such as thyroiditis, hemolytic anemia, and idiopathic thrombocytopenia purpura. Accelerated atherosclerosis among SLE patients is responsible for premature mortality. Drugs specifically approved by the FDA for SLE are limited to aspirin, corticosteroids, hydroxychloroquine and belimumab. Physicians commonly treat disease manifestations with immunosuppressive or corticosteroid therapies that have significant toxicities.

About Resunab
Resunab is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. 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 the production of "Specialized Pro-resolving Lipid Mediators" that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of pro-inflammatory eicosanoids and cytokines. 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.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases. Our lead product candidate, Resunab, is a novel synthetic oral endocannabinoid-mimetic drug that resolves chronic inflammation, bacterial infections, and fibrotic processes. Resunab is currently in Phase 2 studies for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis and skin-predominant dermatomyositis.

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Source: Corbus Pharmaceuticals Holdings Inc