In the trial the compound, atacicept (formerly referred to as TACI-Ig), demonstrated a favorable tolerability profile and indicated biological activity consistent with the mode of action.
The primary objective of these two phase Ib clinical studies was to determine the safety and tolerability of atacicept administered subcutaneously or intravenously to patients with systemic lupus erythematosus (SLE).
In both studies, atacicept appeared to be well tolerated across all dose levels and schedules tested in both studies, and clear biologic response corresponding to the mechanism of action of atacicept was observed.
“These positive results show the potential of atacicept for treating patients with SLE,” said Dr Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics. “We are very encouraged by the findings of these studies and the results will be beneficial in designing future studies in this indication.”
ZymoGenetics and Serono are planning to start a phase II study of atacicept later this year in rheumatoid arthritis patients with an inadequate response to TNF inhibitors. The companies are also conducting ongoing phase Ib clinical trials of atacicept in patients with B-cell malignancies in several open label dose escalation safety studies.