Top line results from Zalicus Synavive Phase 2b study in rheumatoid arthritis

Sep 10 2012

Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced top line results from its randomized, double-blind, placebo-controlled, Phase 2b clinical trial of Synavive® in rheumatoid arthritis (RA).

“In the absence of a clinically meaningful benefit with Synavive compared to its active glucocorticoid component, Zalicus will discontinue further clinical development with Synavive. These results are not only disappointing to Zalicus, but also to the many steroid-dependent patients who are seeking a safer treatment alternative”

The Phase 2b trial demonstrated that patients treated with Synavive achieved a statistically significant improvement in signs and symptoms of moderate to severe RA compared to placebo, as measured by Disease Activity Score (DAS28-CRP), after 12 weeks of treatment, which represents a -0.9 change from baseline for Synavive (approximately 17% improvement) compared to a -0.5 change from baseline for placebo (approximately 10% improvement), but missed the key secondary endpoint of demonstrating a meaningful clinical benefit, assessed by DAS28-CRP, compared to prednisolone 2.7mg, the active glucocorticoid component in Synavive.

"In the absence of a clinically meaningful benefit with Synavive compared to its active glucocorticoid component, Zalicus will discontinue further clinical development with Synavive. These results are not only disappointing to Zalicus, but also to the many steroid-dependent patients who are seeking a safer treatment alternative," said Mark H.N. Corrigan, MD, CEO of Zalicus. "Going forward we will focus our resources and efforts on advancing the clinical development of our ion channel programs including Z160, our first-in-class treatment for neuropathic pain which recently advanced into the first of two Phase 2a clinical trials, and Z944, our novel, oral, T-type calcium channel blocker which is completing multiple Phase 1 studies and if successful will advance into Phase 2 development in the first half of 2013."

Source Zalicus Inc.