Anabasum is a synthetic endocannabinoid mimetic drug, meaning it mimics the action of endocannabinoids, which are endogenous molecules that bind to cannabinoid receptors in the nervous system.
The drug activates cannabinoid receptor type 2 (CB2), which is present in activated immune system cells and in fibroblasts, which play a role in tissue scarring and wound healing.
The activation of CB2 receptors has anti-inflammatory effects. It also contributes to the clearance of bacteria and blocks fibrosis (tissue scarring) in several kinds of tissues.
The trial’s principal investigator is Meggan Mackay, MD, an investigator at the Center for Autoimmunity & Musculoskeletal Disease at the Feinstein Institute for Medical Research (FIMR) and professor of molecular medicine at Hofstra Northwell School of Medicine.
Recent data showed that treatment with anabasum (formerly JBT-101) leads to clinical improvements in two other autoimmune diseases, systemic sclerosis and dermatomyositis. The drug candidate’s mechanism of action holds great potential for lupus patients, Mackay said.
“The investigators look forward to testing anabasum’s efficacy, safety, and effects on disease pathways in SLE,” Mackay said in a press release. “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.”
The clinical trial (NCT03093402) is being conducted by Autoimmunity Centers of Excellence (ACE), a basic and clinical research network created by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The program aims to develop effective treatments for autoimmune diseases.
The Phase 2 trial will be held at 15 sites in the U.S. and will include 100 adult lupus patients with active musculoskeletal disease. Involvement of the musculoskeletal system is extremely common in lupus and can precede the diagnosis of the disease.
Clinical manifestations may include arthritis, arthralgia (joint pain), and osteonecrosis (cellular death at the bone).
Those interested in taking part in the trial must be adult lupus patients who meet the updated ACR 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus. Participants must have had at least three months of treatment with an anti-malarial drug such as hydroxychloroquine, or a history of intolerance to such a drug. For more information, visit the clinical trial site here.
Researchers will test three doses of anabasum for three months, with a one-month follow-up. Results will be compared to a placebo treatment. The study will primarily evaluate if anabasum can relieve pain from active musculoskeletal disease. Other analyses of active musculoskeletal disease and patient-reported outcomes will also be assessed.
“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,” said Yuval Cohen, CEO of Corbus. “Anabasum has the potential to offer an oral therapy that provides efficacy and a favorable safety profile without immunosuppression in SLE.”