ZymoGenetics says atacicept studies in lupus yield promising results

By E. Janene Geiss

Philadelphia, July 25 - ZymoGenetics, Inc. announced Tuesday preliminary positive results from two phase 1b clinical trials in patients with systemic lupus erythematosus treated with atacicept that demonstrated a favorable tolerability profile and indicated biological activity consistent with the mode of action.

ZymoGenetics and its partner, Serono SA, said they plan to present full results of these clinical studies at a medical meeting later this year, according to a company news release.

The primary objective of these two studies was to determine the safety and tolerability of atacicept, formerly referred to as TACI-Ig, administered subcutaneously or intravenously to patients with lupus.

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, and clear biologic response corresponding to the mechanism of action of atacicept was observed, officials said.

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 (four weekly doses) of atacicept or a placebo.

In the study with intravenous administration, 24 patients were enrolled and patient cohorts received single or repeated doses (two doses 21 days apart) of atacicept or a placebo.

All patients were monitored during and for several weeks after for safety, officials said. The predominant adverse event noted was a mild injection site reaction.

ZymoGenetics and Serono said they 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 said they also are conducting ongoing phase 1b clinical trials of atacicept in patients with B-cell malignancies in several open-label dose escalation safety studies.

ZymoGenetics and Serono are developing atacicept for the treatment of autoimmune diseases and B-cell malignancies.

Serono is a Geneva, Switzerland, biotechnology company.

ZymoGenetics is a Seattle biopharmaceutical company.

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