Excitement is building for Corbus Pharmaceutical’s Phase 3 clinical trial testing the safety and effectiveness of their new drug lenabasum in dermatomyositis patients. Lenabasum works by resolving inflammation and scarring and stopping new inflammation from developing. One good thing about this treatment is that it does not suppress the inflammatory process, like prednisone and other myositis medications. It also has few side effects.
Results of earlier clinical trials in dermatomyositis, systemic sclerosis (scleroderma), and cystic fibrosis have been very promising. Additional clinical studies are being conducted and/or planned to confirm these early results and support the FDA’s approval process.
Recruitment for the Phase 3 trial in dermatomyositis is expected to start by the end of this year, and TMA has received many questions about this drug, which we asked Corbus to respond to. Here are the company’s answers:
Is lenabasum only effective for the skin symptoms in dermatomyositis, or will it also be tested for the muscle weakness and pain of myositis?
The upcoming Phase 3 trial is testing the efficacy of lenabasum on many manifestations of DM, including muscle, skin, and lung involvement. Patients will be asked about symptoms such as pain and fatigue.
Are there plans to test it with children for juvenile dermatomyositis, and when?
The upcoming Phase 3 trial is for adults only. Depending on the results of this study, there is a potential for testing lenabasum in pediatric patients in the future. Adult patients who were diagnosed with JDM as children would be potentially eligible for the upcoming Phase 3 study.
Will it be tested with other forms of myositis, such as polymyositis, necrotizing myopathy, and antisynthetase syndrome (which often includes interstitial lung disease)?
At this time, there are no planned trials for these other forms of myositis.
Is lenabasum marijuana?
No, lenabasum was designed to have specific characteristics, such as decreased ability to enter the brain and increased binding to CB2 receptors, which are found on activated immune cells. The CB2 receptor is associated with turning on the resolution of inflammation and fibrosis. Lenabasum is expected to promote the resolution of inflammation without immunosuppression and without the psychotropic effects associated with marijuana.