Alexion Pharmaceuticals has started a Phase II trial in the USA toassess the safety and efficacy of its complement C5 inhibitor, 5G1.1, when given for up to six months to patients with lupus nephritis. In its most severe form, lupus nephritis can progress to kidney failure, severe hypertension or death. This study is in addition to a previously-announced Phase II trial with the humanized monoclonal antibody in non-lupus patients suffering from membranous nephritis, and will look at 5G1.1 treatment over six months in 40 patients.
Pilot study in psoriasis
Meantime, Alexion has completed a Phase I pilot of 5G1.1 in 40 psoriasis patients. The antibody appeared to be safe and well-tolerated, with few adverse events including headache and non-specific pain, but did not influence clinical outcome as measured by the Psoriasis Area and Severity Index score (although favorable trends in certain measure of disease activity were observed). 5G1.1 dose-dependently blocked hemolytic activity in the blood of treated patients and dose-dependently reduced deposition of activated terminal complement in psoriatic plaques.
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