Our research and development activities in the Autoimmune and Inflammatory Diseases therapeutic area focus on proteins that modulate important mechanisms in the development of disease. The Merck Serono division is developing atacicept, a soluble fusion protein, for several indications including rheumatoid arthritis (RA). We completed patient enrollment in our two largest Phase II studies in RA and started another Phase II study in 2008. Data for the first two studies are expected in the second half of 2009.
Systemic lupus erythematosus (SLE), a chronic inflammatory disease where the immune system attacks the body’s own tissues, is an area of high unmet medical need that primarily affects women. A Phase II/III study with atacicept in patients with SLE began in June. We discontinued one study of atacicept in lupus nephritis (LN), a particularly severe form of SLE affecting the kidneys, which was part of the ongoing SLE development program. This Phase II/III study combined atacicept with other medications (mycophenolate mofetil and corticosteroids) and was discontinued because of the occurrence of severe infections. These were thought to be the result of the underlying significant disease activity coupled with the concomitant use of several immunosuppressive medications. We are currently analyzing the data and redesigning the development plan for atacicept in lupus nephritis.
Thanks to its novel mechanism of action, fibroblast growth factor 18 (FGF 18) could be the first treatment for osteoarthritis that stimulates the repair of articular cartilage instead of simply treating the symptoms of this degenerative joint disease. A second Phase I trial in osteoarthritis was initiated at the end of 2008. In July, Merck Serono returned to the Swiss biotech company NovImmune the rights to develop and commercialize the human monoclonal antibody anti-CD 3 (NI-0401).