Teva Provides Update on Edratide for Systemic Lupus Erythematosus
JERUSALEM -- Sep 19, 2007 - Teva Pharmaceutical Industries announced today that the Company's synthetic peptide, edratide (TV-4710), did not meet its primary endpoint in the PRELUDE trial, a Phase 2 clinical trial in patients with systemic lupus erythematosus (SLE). The drug candidate, administered as a subcutaneous weekly injection, was shown to be safe and well-tolerated.
PRELUDE, a randomized, double-blind, placebo-controlled, parallel assignment Phase 2 study, enrolled 340 patients from 12 countries across North America, Latin America, the European Union, Russia, and Israel. The study was designed to assess the efficacy and safety of edratide, with the primary endpoint being the reduction of lupus disease activity over a 26-week treatment period, as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score.Â
Analyses of edratide's performance in other secondary clinical endpoints measured in the trial are still ongoing, and any potential further development plans for this product candidate will not be determined until these additional analyses have been completed.
Edratide (TV-4710) is a synthetic peptide composed of 19 amino-acid residues developed by Teva Pharmaceutical Industries Ltd. based on research done by Prof. Edna Mozes of the Weizmann Institute of Science, Rehovot, Israel. The sequence of the peptide is based on the complementarity determining region 1 (CDR1) of a pathogenic human anti-DNA monoclonal antibody (mAb) that bears the 16/6 idiotype (16/6 Id)(1). This idiotype was found to have clinical relevance in SLE patients. Edratide was tested and found active in several relevant in-vitro and in-vivo models for lupus (ii-iv) and was previously found to be safe for administration to humans in two phase I studies.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 76 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs, primarily for diseases of the central nervous system and auto-immune diseases.
References -0- (i)Â Waisman A, Shoenfeld Y, Blank M, Ruiz PJ, Mozes E. The
Â Â Â Â Â pathogenic human monoclonal anti-DNA that induces experimental
Â Â Â Â Â systemic lupus erythematosus in mice is encoded by a VH4 gene
Â Â Â Â Â segment. Int Immunol 1995; 7:689-696.
(ii)Â Dayan M, Segal R, Sthoeger Z, Waisman A, Brosh N, Elkayam O,
Â Â Â Â Â Eilat E, Fridkin M, Mozes E. Immune response of SLE patients to
Â Â Â Â Â peptides based on the complementarity-determining regions of a
Â Â Â Â Â pathogenic anti-DNA monoclonal antibody. J Clin Immunol 2000;
Â Â Â Â Â 20:187-194.
(iii) Mauermann N, Sthoeger Z, Zinger H, Mozes E. Amelioration of
Â Â Â Â Â lupus manifestations by a peptide based on the complementarity
Â Â Â Â Â determining region 1 of an autoantibody in severe combined
Â Â Â Â Â immunodeficient (SCID) mice engrafted with peripheral blood
Â Â Â Â Â lymphocytes of systemic lupus erythematosus (SLE) patients.
Â Â Â Â Â Clin Exp Immunol. 2004; 137 (3): 513-520
(iv)Â Luger D, Dayan M, Zinger H, Liu J-P, Mozes E. A peptide based on
Â Â Â Â Â the complementarity determining region 1 of a human monoclonal
Â Â Â Â Â autoantibody ameliorates spontaneous and induced lupus
Â Â Â Â Â manifestations in correlation with cytokine immunomodulation.
Â Â Â Â Â J Clin Immunol 2004; 24:579-590.
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