Teva Pharmaceutical Industries Ltd. announced 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.
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 (CDR1) of a pathogenic human anti-DNA monoclonal antibody (mAb) that bears the 16/6 idiotype (16/6 Id). 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 and was previously found to be safe for administration to humans in two phase I studies.