Lenabasum, Investigational Therapy for Lupus, Advances to Phase 2 Clinical Trial

Ana Pena, PhD avatar

by Ana Pena, PhD |

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A Phase 2 clinical trial testing a Corbus Pharmaceuticals’ synthetic cannabinoid derivative – lenabasum (JBT-101) – for lupus patients is underway.

The therapy has no psychotropic properties and is intended to treat joint inflammation associated with lupus. If proven effective, it may offer patients a safer and less expensive alternative to currently prescribed immunosuppressants.

The Phase 2 trial (NCT03093402) is currently recruiting participants at 15 U.S. sites and is led by researchers from Northwell Health’s Feinstein Institute for Medical Research and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).

Lenabasum is an oral medication, that mimics our own natural endocannabinoids. It specifically activates the cannabinoid receptor type 2 (CB2), being similar to the cannabis active compound tetrahydrocannabinol (THC), but designed to preferentially activate receptors on immune cells and fibroblasts — both important for ligaments and wound healing. Because of that, the compound should not exert any effects on the brain.

Lenabaum is designed to resolve inflammation, speed bacterial clearance, and prevent tissue scarring.

Preclinical studies showed that lenabasum is able to resolve inflammation without suppressing the immune system, by shutting down the chronic inflammatory and fibrotic (scarring) process.

“It has been shown in pre-clinical studies that JBT-101 suppresses inflammatory proteins, decreases immune cell migration and promotes molecules that support the resolution of inflammation without suppressing the immune system,” Meggan Mackay, MD, lead investigator and professor at the Feinstein Institute, said in a press release.

Importantly, Phase 2 trials demonstrated that treatment with lenabasum reduces disease symptoms while being safe in patients with other autoimmune rheumatic diseases, such as cutaneous systemic sclerosis (NCT02465437) and dermatomyositis (NCT02466243).

The clinical trial addressing the therapy in lupus will enroll 100 adults with active joint disease and at least moderate pain.

Participants will receive oral doses of lenabasum (three dosing regimens will be tested) or placebo twice daily during 84 days. Follow-up will continue for an additional 28 days.

The therapeutic effects of the treatment will be evaluated primarily by addressing the intensity of patients’ pain at several points during the treatment, using numerical scales. Disease activity and inflammatory mediators are additional outcomes that will be measured.

“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,” Mackay said.

For information about trial recruitment, contact Andrew Shaw at 516-562-2591 or Latchmin Persaud at 516-562-3814.