Lenabasum (formerly known as anabasum, resunab, and JBT-101) is a synthetic investigational compound being developed by Corbus Pharmaceuticals to resolve chronic inflammation in patients with cystic fibrosis, systemic sclerosis, dermatomyositis, and systemic lupus erythematosus.   

How lenabasum works

Lenabasum is an oral medicine that mimics the effects of endocannabinoids (an endocannabinoid-mimetic). Endocannabinoids are naturally-occurring chemicals in the body that are involved in regulating appetite, metabolism, mood, pain, and inflammation.

Lenabasum preferentially binds to cannabinoid receptor type 2 (CB2), which are found primarily on the surfaces of activated immune cells. Upon binding to the CB2 receptors, lenabasum triggers the production of pro-inflammatory mediators, which reduces inflammation. 

Ultimately, lenabasum acts to “turn off” chronic inflammation and halt tissue thickening and scarring (fibrosis) without suppressing the activity of the immune system. It is believed that reducing inflammation could help prevent permanent tissue damage in the lungs of people with cystic fibrosis.

Lenabasum in clinical trials for cystic fibrosis

Preclinical studies done on human lung cells obtained from patients with cystic fibrosis showed that lenabasum stopped the production of two crucial pro-inflammatory cytokines or cell-signaling molecules that trigger inflammation called tumor necrosis factor alpha and interleukin-6.

Lenabasum has been evaluated in a Phase 2 clinical trial (NCT02465450) for the treatment of cystic fibrosis. A total of 85 adults with cystic fibrosis were enrolled in the study that was completed in December 2016. The 16-week, double-blind, randomized, and placebo-controlled trial found that lenabasum demonstrated acceptable safety and tolerability profiles at all doses tested, which ranged from 1 mg to 40 mg daily. 

Treatment with 20 mg of lenabasum twice a day was able to reduce the frequency of acute lung exacerbations. This dosage consistently reduced the number of inflammatory cells and inflammatory mediators found in the sputum. Forced expiratory volume in one second (FEV1, a measure of lung function) was stable throughout the study for both lenabasum and placebo groups.

The most common side effect was a mild dry mouth that was observed in 13 percent of patients who received lenabasum, but not in those who received placebo.

In January 2018, Corbus announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a future Phase 2b clinical trial. This trial will include adolescents, ages 12-17 and its primary endpoint will be the occurrence of lung exacerbations. It aims to enroll 415 patients across 100 clinical sites in North America, Europe, Israel, and Australia. The first patient is expected to be dosed in the first quarter of 2018.

The planned Phase 2b clinical trial also has received a $25 million Development Award from the Cystic Fibrosis Foundation in the U.S.

Other details 

Lenabasum has been designated an orphan drug for the treatment of cystic fibrosis in the U.S. and in Europe. The FDA also granted it fast-track status to speed its development for the possible treatment of cystic fibrosis.

The drug also is being tested in Phase 2 clinical trials as a potential treatment for other diseases such as scleroderma (NCT02465437), dermatomyositis (NCT02466243), and systemic lupus erythematosus (NCT03093402) in which inflammation also is linked to disease progression.

A Phase 3 study of lenabasum for the treatment of diffuse cutaneous systemic sclerosis, called RESOLVE-1 (NCT03398837) was initiated in December 2017.

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