Our research and development work in Rheumatology is centered on molecules that modulate key pathogenic mechanisms. We are investigating the recombinant protein atacicept as a potential treatment for systemic lupus erythematosus (SLE) in a clinical trial. SLE is a chronic autoimmune disease that primarily affects women. As recommended by the Independent Data Monitoring Committee of the trial, the high-dose arm was discontinued in February because the risk-benefit profile for this group of patients was considered unfavorable. The study is being continued with the lower-dose and placebo groups.
We reset the SLE program to Phase II since the optimum dose regimen for Phase III trials still needs to be identified. In 2011, we started a new Phase I study in lupus nephritis (LN), a particularly severe form of SLE affecting the kidneys. Following a fatal cardiovascular event, the study was discontinued. The causality between this fatal event and the administration of atacicept is still being investigated.
Fibroblast growth factor 18 (FGF 18) is another recombinant protein in our rheumatology pipeline. Thanks to its novel mechanism of action, it could be the first disease-modifying treatment for osteoarthritis and the repair of damaged cartilage. We successfully completed the second Phase I trial of this agent in patients with osteoarthritis of the knee joint. Phase II trials are scheduled to begin in 2012. We are also investigating the efficacy of FGF 18 in the treatment of knee cartilage injury in an ongoing Phase II study.
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