Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that its 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 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.
The company added however that the drug candidate, administered as a subcutaneous weekly injection, was shown to be safe and well-tolerated.
Teva said that analyses of edratide's performance in other secondary clinical endpoints measured in the trial were still ongoing, and any potential further development plans for this product candidate would not be determined until these additional analyses had been completed.
Although Teva is best known for generic drugs, it has scored success with ethical drugs too. Most prominent is multiple sclerosis treatment Copaxone, while Parkinson's Disease treatment Azilect has also won acceptance. Teva has announced its intention of launching one ethical drug a year from 2009 to 2015.
Published by Globes [online], Israel business news - www.globes.co.il - on September 19, 2007
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