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Last Update: 10-Sep-12 09:20 ET
Zalicus shares plummet more than 45% following disappointing Phase 2 results
Zalicus (ZLCS $0.74 -0.65) announced top line results from its randomized, double-blind, placebo-controlled, Phase 2b clinical trial of Synavive in rheumatoid arthritis (RA). 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 approximately 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.
