Atacicept to be examined in Ph II RA trial

Seattle, USA-based drug developer ZymoGenetics and Swiss biotechnology company Serono have initiated a Phase II trial of their co-developed autoimmune disease treatment atacicept. The study, which is designed to examine the agent's efficacy against rheumatoid arthritis, will enroll patients who have inadequately responded to prior anti-tumor necrosis factor-based therapies.

The firms added that they will seek to recruit around 320 patients, who will be selected on the basis that they have had the condition for at least one year and have experienced at least three months of failed TNF-based therapy. Participants will be randomized to receive one of three doses of the drug (25mg, 75mg or 150mg) or placebo, in addition to background methotrexate treatment. Loading doses will be given twice weekly for four weeks, followed by a weekly maintenance dose for 21 weeks. The primary endpoint is defined as the rate of Amercian College of Rheumatology-20 (ACR26) response at week 26.

The companies added that they are both in discussion with the US Food and Drug Administration regarding the initiation of a Phase II trial of atacicept in systemic lupus erythematosus, following the successful completion of a Phase Ib study for this indication earlier in the year.