NORWOOD, MA--(Marketwired - December 22, 2017) - Corbus Pharmaceuticals Holdings, Inc. (CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting chronic, serious inflammatory and fibrotic diseases, announced today the initiation of a Phase 2 clinical study of anabasum for the treatment of systemic lupus erythematosus ("SLE"). SLE is an uncommon autoimmune disease associated with significant morbidity, reduction in quality of life and a 2.4-fold increase in standard mortality rate. The disease affects primarily women of child-bearing age, with increased prevalence and morbidity among African Americans and other minority populations.
This Phase 2 SLE clinical trial is being conducted by the Autoimmunity Centers of Excellence (ACE) program, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Cynthia Aranow, M.D., of the Feinstein Institute for Medical Research (FIMR), Manhasset, NY, is Principal Investigator for ACE, and Meggan Mackay, M.D., M.S., is Principal Investigator for the clinical trial of anabasum in SLE. 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.
Dr. Mackay commented, "We are grateful to the NIH for its support of this study. The investigators look forward to testing anabasum's efficacy, safety, and effects on disease pathways in SLE. There is a need for new treatments for this disease, especially treatments that do not increase risk of infection, which is a frequent cause of hospitalizations and death. Recent data has shown clinical benefit of anabasum in two other autoimmune diseases, systemic sclerosis and dermatomyositis, and its mechanism of action suggests great potential for SLE."
The randomized, double-blind, placebo-controlled, Phase 2 trial will be conducted at 15 sites in the United States and will enroll 100 adult SLE patients with active musculoskeletal disease, which is the most common disease manifestation of SLE. Subjects will be randomized in a 1:1:1:1 ratio to one of four cohorts to receive placebo or three different doses of anabasum for 3 months, with 1-month follow-up. The primary efficacy outcome assesses pain from active musculoskeletal disease, and secondary efficacy outcomes include other assessments of active musculoskeletal disease, overall disease activity using SLE Responder Index, SLE Disease Activity Index ("SLEDAI") and British Isles Lupus Activity Group ("BILAG") scoring systems, and patient-reported outcomes.
Yuval Cohen, Chief Executive Officer of the Company, commented, "This SLE Phase 2 study marks the start of clinical testing in a third potential autoimmune disease indication affecting approximately 300,000 people in the United States. Anabasum has the potential to offer an oral therapy that provides efficacy and a favorable safety profile without immunosuppression in SLE."
For more information on this study, please visit ClinicalTrials.gov and reference Identifier
About Systemic Lupus Erythematosus
Systemic lupus erythematosus is an uncommon, multi-system autoimmune disease. SLE occurs more often in women of child bearing age. According to the CDC, SLE affects between 161,000 - 322,000 people in the United States. SLE has many 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 cumulative organ 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, infections and active disease can be responsible for premature mortality among people with SLE. Drugs specifically approved by the FDA for treatment of SLE are aspirin, corticosteroids, hydroxychloroquine and belimumab. Physicians commonly treat disease manifestations with immunosuppressive therapies that have significant toxicities.
Anabasum is a synthetic, oral, small-molecule, selective cannabinoid receptor type 2 (CB2) agonist that preferentially binds to CB2 expressed on activated immune cells and fibroblasts. CB2 activation triggers physiologic pathways that resolve inflammation, speed bacterial clearance and halt fibrosis. CB2 activation also induces 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 multiple inflammatory mediators. Through activation of CB2, anabasum also is designed to have a direct effect on fibroblasts to halt tissue scarring. Anabasum is believed to induce resolution rather than immunosuppression by triggering biological pathways to turn "off" chronic inflammation and fibrotic processes. Anabasum has demonstrated promising potency in preclinical models of inflammation and fibrosis. Preclinical and human clinical studies have shown anabasum to have a favorable safety, tolerability and pharmacokinetic profile. Further, the drug has demonstrated clinical benefit and positive impact on inflammatory and immunological markers in Phase 2 studies in diffuse cutaneous systemic sclerosis, dermatomyositis and cystic fibrosis.
Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Company's lead product candidate, anabasum, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes. Anabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
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