Teva's edratide disappoints in Ph II SLE trial

Israel-hedquartered Teva Pharmaceutical Industries says that its synthetic peptide, edratide (TV-4710), did not meet its primary endpoint in the PRELUDE trial, a Phase II clinical study in patients with systemic lupus erythematosus. 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 II trial, 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.