Feinstein Institute, NIH launch groundbreaking clinical trial for new lupus medication

Trial examines use of synthetic endocannabinoid mimetic with no psychotropic properties to treat lupus inflammation

MANHASSET, NY – Researchers at Northwell Health’s Feinstein Institute for Medical Research are leading a nationwide National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) sponsored clinical trial testing the efficacy of a synthetic cannabinoid derivative with no psychotropic properties for the treatment of joint inflammation in lupus. If proven effective, the drug, called JBT-101 (lenabasum), could provide lupus patients with an alternative to current prescription immunosuppressant therapies, which are expensive and often have numerous side effects.

Lupus is an autoimmune disease that affects 1.5 million Americans and causes the immune system to lose the ability to differentiate between foreign agents and healthy tissue. The immune system becomes hyperactive, attacking healthy tissue while causing inflammation and damage to joints, skin and internal organs. Patients experience a host of symptoms, from extreme fatigue to painful or swollen joints and skin rashes. Current therapies for lupus include immune-suppressing drugs that decrease disease flare-ups and inflammation. However, these treatments come with significant side effects, such as increased risk of infection.

Meggan Mackay, MD, MS, lead investigator and professor at the Feinstein Institute, will examine the effects of JBT-101(lenabasum) on musculoskeletal pain in lupus patients. JBT-101(lenabasum) is an oral selective cannabinoid receptor type 2 (CB2) agonist that has a similar structure to tetrahydrocannabinol (THC) but is designed to preferentially activate receptors on immune cells and therefore does not affect brain function.

“It has been shown in pre-clinical studies that JBT-101suppresses inflammatory proteins, decreases immune cell migration and promotes molecules that support the resolution of inflammation without suppressing the immune system,” said Dr. Mackay. “We are extremely excited to have the support of the NIH and Corbus Pharmaceuticals to test this investigational drug candidate in lupus as it has proven to be successful in smaller studies of other disorders where inflammation is a symptom. Given the significant side effects of current treatments for lupus, this drug may have enormous potential for patients who do not want to take immunosuppressants, or who haven’t experienced relief from current therapies.”

Dr. Mackay’s lab will be the lead site for this 15-site, two-year study which plans to recruit 100 patients in total. If you are an adult with lupus and active joint disease with at least moderate pain and are interested in finding out more about this clinical trial, contact Andrew Shaw at 516-562-2591 or Latchmin Persaud at 516-562-3814.

This trial is supported by the (NIAID) under trial number NCT03093402.


About the Feinstein Institute

The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in New York. Home to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the Feinstein Institute includes 4,000 researchers and staff who are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org.

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