ZymoGenetics Releases Preliminary Findings From Atacicept (TACI-Ig) Phase 1b Studies in Patients With Lupus
Tuesday July 25, 6:00 am ET
Encouraging Tolerability and Biologic Activity Observed
SEATTLE, July 25 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN - News) today announced preliminary positive results from two Phase 1b clinical trials in patients with systemic lupus erythematosus (SLE) treated with atacicept (formerly referred to as TACI-Ig). The results demonstrated a favorable tolerability profile and indicated biological activity consistent with the mode of action. ZymoGenetics and its partner, Serono S.A., plan to present full results of these clinical studies at a medical meeting later this year.
"These positive results show the potential of atacicept for treating patients with SLE," said Nicole Onetto, M.D., 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."
The primary objective of these two Phase 1b clinical studies was to determine the safety and tolerability of atacicept administered subcutaneously or intravenously to patients with SLE. Secondary objectives included examination of the relationship between the atacicept dose and schedule with markers of biologic activity and disease activity. 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.
Both clinical studies were multi-center, double-blind, randomized, placebo-controlled, dose-escalating studies. In the subcutaneous administration study, 49 patients were enrolled and patient cohorts received single or repeated doses (4 weekly doses) of atacicept or placebo. In the study with intravenous administration, 24 patients were enrolled and patient cohorts received single or repeated doses (2 doses 21 days apart) of atacicept or placebo. All patients were monitored during and for several weeks after for safety. The predominant adverse event noted was a mild injection site reaction (redness of skin or pain at the injection site).
ZymoGenetics and Serono are planning to start a Phase 2 study of atacicept later this year in rheumatoid arthritis patients with an inadequate response to TNF inhibitors. The companies are also conducting ongoing Phase 1b clinical trials of atacicept in patients with B-cell malignancies in several open label dose escalation safety studies.
About Atacicept
ZymoGenetics and Serono are developing atacicept (formerly referred to as TACI-Ig) for the treatment of autoimmune diseases and B-cell malignancies. Atacicept is a soluble receptor that binds to BLyS and APRIL, TNF family cytokines that promote B-cell survival and the production of autoantibodies that are associated with certain autoimmune diseases such as systemic lupus erythematosus (SLE). Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, SLE and B-cell malignancies. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies. |
