Synavive is a product candidate with a novel mechanism designed to enhance the anti-inflammatory benefits of glucocorticoids without the associated dose-dependent side effects. Developed in a uniquely engineered formulation, Synavive is comprised of the cardiovascular agent dipyridamole, and very low dose of the glucocorticoid prednisolone. Synavive is thought to act through a novel multi-target mechanism of action in which dipyridamole selectively amplifies prednisolone’s anti-inflammatory activities without increases in adverse effects typically associated with higher doses of glucocorticoids.

 

Synavive is in Phase 2 clinical development and has demonstrated anti-inflammatory effects, rapid onset of action and tolerable safety profiles in clinical studies to-date including rheumatoid arthritis, and hand and knee osteoarthritis.

 

Clinical Development

Zalicus is developing a modified-release, once-daily capsule formulation of Synavive for arthritis. This formulation may provide greater synergy through co-exposure and an improved tolerability profile. Synavive has demonstrated treatment benefit over placebo in Phase 2 studies in rheumatoid arthritis, and hand and knee osteoarthritis and has been generally well tolerated in clinical studies to date with no serious adverse events reported from subjects taking Synavive.