Corbus Pharmaceuticals have announced that they will go ahead with a Phase 3 study investigating the drug lenabasum as a potential treatment for dermatomyositis. For more information, you can view the original press release here at Corbus’ website.
Dermatomyositis is a serious rare illness that is part of a group of muscle disorders called inflammatory myopathies, which can cause chronic muscle inflammation and weakness. People have different experiences of dermatomyositis, but some common symptoms of the disease include a skin rash, weak and inflamed muscles, feeling unwell, and extreme tiredness, amongst others. Dermatomyositis may make it difficult for people to carry out normally easy tasks, such as climbing stairs, lifting objects, or getting up from a chair.
Lenabasum is an investigational drug that is being researched as a potential therapy for dermatomyositis. It is a small-molecule agonist of the CB2 receptor. It is thought to work by selectively binding to this receptor, which, when activated, may help to resolve inflammation, stop fibrosis (connective tissue scarring), and speed bacterial clearance.
Research into Lenabasum
Lenabasum has shown promising results in previous preclinical models of fibrosis and inflammation, and subsequent human clinical studies support its safety and tolerability in people. A Phase 2 clinical trial found that lenabasum was associated with improvement in inflammatory and immunological markers in dermatomyositis, as well as in cystic fibrosis and systemic sclerosis.
The Phase 3 Study
Following the positive results from the Phase 2 trial, Corbus is planning to carry out a one year Phase 3 study of lenabasum in people with dermatomyositis. The study, which has been designed with guidance from the FDA, is expected to begin later on this year.
It will be a double-blind, randomised study that compares the effects of lenabasum to those of a placebo in around 150 people with dermatomyositis. The trial is designed to investigate how safe and tolerable the drug is, and the primary study endpoint will be how effective the drug is at improving the symptoms of myositis (as measured by an ACR/EULAR 2016 Total Improvement Score).