Lenabasum is a potential lupus therapy that Corbus Pharmaceuticals is developing.

The company is also evaluating it as a possible treatment for systemic sclerosis, cystic fibrosis, and dermatomyositis.

How lenabasum works

Lenabasum is a synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and tissue scarring. It imitates the action of endocannabinoids, natural substances that play a role in communication in the brain and body. This communication affects many important functions, including how a person feels, moves, and acts.

Corbus said lenabasum activates a protein known as cannabinoid receptor type 2 , or CB2. It is found in activated immune system cells and in fibroblasts, cells involved 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 scarring in different tissues. Lenabasum is designed to control inflammation without suppressing the immune system. Lupus is commonly treated with immunosuppressants that reduce normal immune response but that can be toxic.

Lenabasum in clinical trials for lupus

Lenabasum is being evaluated as a lupus treatment in a Phase 2 clinical trial (NCT03093402). Researchers are recruiting participants at 15 U.S. sites.

The Autoimmunity Centers of Excellence, a research network created by the National Institute of Allergy and Infectious Diseases, is conducting the trial. The institute is part of the National Institutes of Health. The goal of the autoimmunity centers program is to develop treatments for autoimmune diseases.

Researchers said the trial will include 100 adults with lupus, aged 18 to 70, who have an active musculoskeletal disease. Problems with the musculoskeletal system, which is made up of bone, muscle, cartilage, and connective tissue, are common in lupus, and can precede the diagnosis of the disease.

There will be four groups of trial participants. Three will receive various doses of lenabasum and one a  placebo for 84 days. The research team will follow the participants for 28 days after treatment.

Researchers will assess patients’ condition on day 1 of the study, then every other week twice, followed by every four weeks three times — or a total of six times. A key measure of lenabasum’s effectiveness will be changes in patients’ maximum daily numeric pain rating scale score between the beginning of the trial and each evaluation.

 

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