The SYNERGY trial is designed to evaluate the safety and efficacy of Synavive, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in RA patients.
The company expects to present the top-line results of the trial in the third quarter of 2012.
Zalicus president and CEO Mark Corrigan said, "Synavive has already demonstrated early and encouraging signs of clinical efficacy in RA in a previously completed Phase 2a study with statistically significant improvements in ACR20 and DAS28 scores compared to placebo."
The primary objective of the 12-week, five-arm, global, double-blind, placebo-controlled study is to evaluate Synavive efficacy compared to placebo.
The additional secondary objectives include evaluating the efficacy of Synavive compared to its individual components as well as how Synavive performs in comparison to 5mg of Prednisone.