Idorsia initiates a multiple-dose efficacy and safety study with cenerimod for the treatment of systemic lupus erythematosus - Seite 2

Guy Braunstein, MD and Head of Global Clinical Development, commented:

"This study is based on a clinical pharmacology program in healthy volunteers and a Phase 2 safety study in patients with lupus, which showed that cenerimod reduced circulating lymphocytes in a dose-dependent manner and was safe and well tolerated at doses up to 4 mg. It has been designed to include input from health authorities. As background therapy may confound the treatment effect, the protocol recommends keeping SLE medications as stable as possible during the double-blind treatment period. The study also considers important patient perspectives, such as the overall quality of life and debilitating symptoms like fatigue."

Notes to the editor

About systemic lupus erythematosus
SLE - known more simply as "lupus" since it is the most common form of lupus - is an autoimmune disease, which means that the body's immune system malfunctions and attacks the body's own tissues, causing inflammation and organ damage. Some autoimmune diseases affect individual organs, but in the case of lupus, most parts of the body can be affected: most commonly the skin, joints, gut, blood cells, and lungs, as well as the brain, heart, and kidneys.

Lupus can range from mild to life-threatening and can randomly become worse (so-called 'flare ups') and then better again, which can make living with lupus unpredictable and its impact on day-to-day life wide-ranging. Around five million people worldwide have a form of lupus and while it affects people of all races, genders, and ages, as much as ninety percent of diagnosed cases are in women. The condition is also more common in people of Afro-Caribbean and Asian origin compared to Caucasians and is likely to affect these ethnic groups more severely.

There is no cure for lupus. Most people with lupus are prescribed a combination of different medications including anti-inflammatory, anti-malarial drugs, corticosteroids, immunomodulators.

About cenerimod in systemic lupus erythematosus
How and why lupus affects the immune system's defense mechanisms is still not fully understood. However, T and B lymphocytes are considered the key immune system cells that contribute to the symptoms of the disease, because their normal development and mechanism for developing tolerance to the body's own tissues has malfunctioned in lupus.