ZymoGenetics, Serono say results of TACI-Ig phase 1b trial in rheumatoid arthritis are promising

By E. Janene Geiss

Philadelphia, June 26 - ZymoGenetics, Inc. and Serono announced Monday what they described as favorable results from a phase 1b clinical trial with TACI-Ig in 73 patients with rheumatoid arthritis with patients showing a decrease in immunoglobin and serum rheumatoid factor levels.

TACI-Ig is a soluble fusion protein that neutralizes molecules implicated in the pathogenesis of several autoimmune diseases, according to a company news release.

TACI-Ig appeared to be well-tolerated across the full range of dose levels and schedules tested, the companies said.

Clear biologic effect was observed as patients showed schedule and dose-dependent decreases in the levels of immunoglobulin and serum rheumatoid factor levels, officials said.

Although this study was not specifically designed to evaluate efficacy, encouraging trends were observed in ACR and DAS 28 scores, commonly used measurements of clinical benefit, officials said.

In the study, patients showed reductions of several biomarkers typically found in rheumatoid arthritis patients, including IgM, IgA and IgG reductions of 54%, 37% and 21% respectively. Also observed was a reduction of peripheral blood B-cell levels with a maximum decrease of 30% to 40% and 40% to 45% reduction of IgM-RF, IgA-RF and IgG-RF, officials said.

Based on these promising results, ZymoGenetics and Serono said they expect to begin the phase 2 clinical program of TACI-Ig in patients with rheumatoid arthritis in the second half of 2006.

The results were recently presented at the annual European Congress of Rheumatology meeting.

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

TACI-Ig is a soluble receptor that binds to BlyS and APRIL, TNF family cytokines that promote B-cell survival and the production of harmful autoantibodies, which cause certain autoimmune diseases such as systemic lupus erythematosus.

ZymoGenetics is a Seattle biotechnology company.

Serono is a Geneva, Switzerland, biotechnology company.

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