Treatment for Lupus (Lupuzor TM)
Background
Lupus is a chronic, potentially life-threatening autoimmune disease. By 2010 there will be an estimated 1.4 million people diagnosed in the seven key markets. Lupus is an inflammatory disease which attacks multiple organs such as the skin, joints, kidneys, blood cells, heart and lungs. There is currently no cure or specific treatment.
ImmuPharma's compound
Lupuzor TM (previously known as IPP-201101) has a novel mechanism of action aimed at modulating the body’s immune system so it does not attack healthy cells without causing adverse side effects. It has the potential to halt the progression of the disease in a substantial proportion of patients.
Lupuzor TM has successfully completed a European Phase II study. This study in Lupus patients was a proof of concept, dose ranging, safety, multi-centre European study. The proof of concept was assessed by measuring the decrease of anti dsDNA antibodies as a surrogate marker for efficacy and IL10, a cytokine, to ascertain its mechanism of action. The drug was administered 3 times by subcutaneous injections 2 weeks apart at doses of 200 µg and 1000 µg and the patients were monitored one month after treatment stop.
Lupus patients who received Lupuzor TM on only 3 occasions, 2 weeks apart, demonstrated a significant clinical improvement in their condition in addition to the decrease of their biomarkers.
The phase II trial of Lupuzor TM met its primary end-points. The study was designed to measure biomarkers, including reduction in anti-dsDNA auto-antibodies and increase in IL-10. Many of the patients that were treated with the drug showed reduction in their auto-antibodies and showed also significant improvement in their condition.
Lupuzor TM is a drug that specifically modulates the immune system of Lupus patients by modifying the behaviour of some of the key cells involved in the pathogenesis of the disease. The clinical profile of Lupus patients is generally assessed by standardized scales such as SLEDAI (SLE Disease Activity Index): the lower the score, the better the condition of the patient. During this Phase II study, the SLEDAI scores were assessed on multiple occasions even though the study was not designed or powered to demonstrate clinical benefit as primary endpoint due to the short treatment period.
Lupuzor TM is now in a large phase IIb study being conducted by ImmuPharma in 200 patients in Europe and Latin America. Headline efficacy results are expected in 2008.
More information on Lupus is available from a number of resources including LUPUS UK
