ZymoGenetics in Lupus trial

Published: 28-Jul-2004

ZymoGenetics has started a clinical study of TACI-Ig, which is being developed in collaboration with Serono, in patients with an autoimmune disease called systemic lupus erythematosus (SLE).


ZymoGenetics has started a clinical study of TACI-Ig, which is being developed in collaboration with Serono, in patients with an autoimmune disease called systemic lupus erythematosus (SLE).

Over one million patients have some form of lupus in the US; 90% of these patients are women. Approximately 150,000 patients have a severe form of the disease that could be treated with a drug such as TACI-Ig. Standard care for SLE consists of steroid therapy and immunomodulatory drugs, and these treatments may have severe side effects. The Phase 1b dose escalation study is designed to evaluate the safety and pharmacokinetics of TACI-Ig. The study follows the successful completion of a Phase I study of TACI-Ig in healthy volunteers. Additionally, ZymoGenetics and Serono are also planning clinical trials to test TACI-Ig in rheumatoid arthritis and are considering other B cell disorders.

TACI-Ig is a soluble fusion protein that links the extracellular portion of the TACI receptor to the Fc portion of human immunoglobulin (Ig). TACI has been shown to bind 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 SLE. TACI has been shown to affect several stages of B cell development and may inhibit the survival of the cells responsible for making antibodies.

'TACI-Ig shows tremendous potential for addressing the unmet medical needs of lupus patients,' said Dr Bruce Carter, president and ceo of ZymoGenetics. 'Current therapies for lupus are inadequate. If successfully developed, TACI-Ig could help an enormous number of patients and thus represents a significant market opportunity.'

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