Lupus (Systemic Lupus Erythematosus or SLE) is a chronic life-threatening autoimmune, inflammatory disease which is thought to affect some 5 million individuals worldwide. It can affect multiple organs such as skin, joints, kidneys, blood cells, brain, heart and lungs. At present, there is no cure and the current standard of care consists of drugs which have many side-effects and limited efficacy.
A drug discovery company has developed a potential treatment for Lupus. The lead product has completed dosing patients in a Phase III trial with a Special Protocol Assessment and fast track designation.
The potential treatment for Lupus has a novel mechanism of action aimed at modulating the body’s immune system by modifying the behaviour of some of the key cells involved in the pathogenesis of the disease so it does not attack healthy cells. Hence, it does not cause adverse side effects.
This targeted approach marks a paradigm shift in treating autoimmune disease. Instead of shutting down otherwise healthy immune responses the T-cells are suppressed, leaving the immune system deleted from unwanted deleterious cells but intact as normal, beneficial immune cells are concerned.
The potential treatment has successfully completed Phase I, Phase IIa and Phase IIb studies and is currently in the final testing Phase III.
This novel treatment for Lupus has the potential to halt the progression of the disease in a substantial proportion of patients.
Despite the need for an effective treatment, there is barely any new therapy approved for treatment of the condition over the past 50 years. As such, there clearly exists an unmet medical need for a drug that has a strong efficacy and safety profile.
There is currently no cure not for Lupus the current standard of care is not ideal. This potential new treatment has demonstrated good efficacy and safety results in clinical trials.