Teva Provides Update on PRELUDE Trial
Israeli drug company Teva Pharmaceutical said edratide, its synthetic peptide, did not meet its primary endpoint in the Phase II PRELUDE trial in patients with systemic lupus erythematosus.
PRELUDE, a randomized, double-blind, placebo-controlled, parallel assignment Phase II 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 (TV-4710), with the primary endpoint being the reduction of lupus disease activity over a 26-week period, Teva said.
Analyses of edratide’s performance in other secondary clinical endpoints measured in the trial are ongoing, and any potential further development plans will not be determined until these analyses are complete, the company added.
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