New data has been released about the effects of lenabasum, an experimental drug, on patients with systemic sclerosis and dermatomyositis. Corbus, who are developing lenabasum, are planning to present the data from two open-label extension studies at the American College of Rheumatology’s annual meeting. For more detailed information about this, you can view the source press release here, at Corbus’ website.
About Systemic Sclerosis
Systemic sclerosis is a rare condition that can cause patches of hardened and thickened skin, and may also affect blood circulation and internal organs, such as the heart, lungs, or kidneys. Systemic sclerosis is thought to be caused in part by changes to the body’s immune system, which cause cells in the connective tissue to make too much collagen. This may cause the scarring and thickening of tissue that many people with the condition experience.
Dermatomyositis is a type of acquired muscle disease that is associated with a skin rash and can cause muscle weakness and inflammation. The symptoms may come on gradually. According to Corbus, 80,000 people in the US, EU, and Japan are affected by dermatomyositis.
Corbus is developing lenabasum as a potential treatment for both systemic sclerosis and dermatomyositis. Lenabasum is an investigational small-molecule oral drug, which is thought to work by selectively binding to the CB2 receptor. Lenabasum has been tested in several preclinical and clinical studies and is now being further studied in open-label extension studies of patients with systemic sclerosis and dermatomyositis.
Data From Patients with Systemic Sclerosis
Lenabasum is showing encouraging effects in patients with systemic sclerosis. According to Corbus’ announcement, after eighteen months in the open-label extension study, patients showed a mean improvement in modified Rodnan Skin Score (a measure of skin thickening) of -10.7 points. Furthermore, 87% of patients showed a score of at least -5, which is approximately the point at which the improvement is considered to be medically important, and 60% showed an improvement of at least -10. Patients also showed improvements across other measures, including skin symptoms, itch, overall health, and patient-reported disability and function.
Data From Patients with Dermatomyositis
Data from a twelve-month extension study of lenabasum in patients with dermatomyositis has also been shared. Patients who took part in this showed an average improvement of -17.6 points after twelve months on a composite score of inflammatory skin involvement (the Cutaneous Dermatomyositis Activity and Severity Index). A score of -4 to -5 is medically important. Patient reports and physician reports also reported improvements across several symptoms.
So far, lenabasum appears to have a favourable safety profile in patients with systemic sclerosis and dermatomyositis, with no severe adverse events reported yet.
An ongoing Phase 3 study called Resolve-1 is further investigating the use of lenabasum in systemic sclerosis, and there are plans for a year-long double-blind Phase 3 study that will compare the effects of lenabasum to those of a placebo in patients with dermatomyositis towards the end of this year.