ZymoGenetics, Serono present positive results for atacicept

The primary objective of the dose-escalating phase Ib trial, which included patients with systemic lupus erythematosus (SLE) in 6 cohorts, was to determine the safety and tolerability of atacicept administered subcutaneously. Secondary objectives included examining the effects of various dose and schedule regimens on markers of biologic activity and disease activity.

The results showed that atacicept was well tolerated across all dose levels. In addition, atacicept therapy was associated with clear biologic activity, as shown by dose-dependent reductions in several biologic markers.

The predominant adverse event noted was a mild to moderate local injection site reaction, which was observed in 50% of atacicept subjects. Few notable differences were observed between atacicept and placebo in the nature, severity or frequency of adverse events.

“The phase Ib results are very encouraging and we are looking forward to moving the clinical development of atacicept in patients with SLE to phase II,” said Franck Latrille, senior executive vice president, Corporate Global Product Development at Serono.

The companies are planning to initiate the trial in SLE in mid-2007. ZymoGenetics and Serono are developing atacicept for the treatment of autoimmune diseases and B-cell malignancies.