(By Balaseshan) Zalicus Inc. (NASDAQ:ZLCS) shares plunged in early
trade after the biopharmaceutical company said it will discontinue
further clinical development of Synavive in rheumatoid arthritis.
The company announced top line results from its randomized,
double-blind, placebo-controlled, Phase 2b clinical trial of Synavive in
rheumatoid arthritis (RA). The company said it achieved primary
endpoint compared to placebo but missed key secondary endpoint compared
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, 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 Corrigan, CEO of Zalicus.
Looking ahead, the company will focus its resources and efforts on advancing the clinical development of ion channel programs.
programs includes Z160, its first-in-class treatment for neuropathic
pain which recently advanced into the first of two Phase 2a clinical
trials, and Z944, its 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.
ZLCS is trading down 25.90% at $1.03 on Monday. The stock has been trading between $0.71 and $1.62 for the past 52 weeks.