Our research and development work in Autoimmune and Inflammatory Diseases focuses on proteins that modulate key pathogenic mechanisms in these diseases. We are developing the recombinant protein atacicept for autoimmune diseases such as systemic lupus erythematosus (SLE). This innovative compound blocks the two immunomodulatory factors APRIL and BLyS. They are important for the survival and the proliferation of lymphocytes that trigger an abnormal immune reaction against the patient’s own normal tissues.
SLE is a chronic, autoimmune disease that mainly affects women and is an area of great unmet medical need. We are currently enrolling patients into a Phase II/III clinical trial with atacicept in SLE. In the second half of 2009, a competitor published positive data from two Phase III trials in SLE involving a BLyS-targeted compound administered intravenously. These results are encouraging for us since atacicept targets not only BLyS but also APRIL, and is administered by subcutaneous injection, which is more convenient for patients than an infusion.
In 2008, we discontinued a Phase II/III study in lupus nephritis (LN), a particularly severe form of kidney failure, owing to infections that were probably the result of significant disease activity coupled with the concomitant use of several immunosuppressive medications. Having evaluated the trial data, we are now adjusting the clinical development plan for atacicept in lupus nephritis.
We analyzed the results of our Phase II trials with atacicept in rheumatoid arthritis (RA). Although we noted strong biological effects and indications of clinical benefit, the efficacy data did not correspond to our criteria for a move to Phase III.
Thanks to its novel mechanism of action, fibroblast growth factor 18 (FGF 18) could be the first disease-modifying treatment for osteoarthritis and the repair of cartilage damaged following injury. In the laboratory it has been shown to stimulate the regeneration of articular cartilage defects. FGF 18 may thus support the healing of degenerative joint disease instead of simply treating its symptoms. Patient enrollment was completed early for two Phase I clinical trials that are currently underway.
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