Biopharmaceutical company Zalicus Inc. (ZLCS: Quote) said Monday that it will discontinue the development of its rheumatoid arthritis drug Synavive, citing the absence of a clinically meaningful benefit with Synavive compared to its active glucocorticoid component. Following the announcement, the company's shares are down 25 percent in the regular trading session.
Cambridge, Massachusetts-based Zalicus is focused on developing novel treatments for pain and inflammation, using its selective ion-channel modulation platform and combination high throughput screening capabilities.
Zalicus announced top-line results from its randomized, double-blind, placebo-controlled, Phase 2b clinical trial of Synavive in rheumatoid arthritis or RA. The company noted that the drug achieved the primary endpoint compared to placebo in the trial, but missed the key secondary endpoint compared to prednisolone.
Last June, Zalicus initiated a phase 2Ib clinical trial, dubbed SYNERGY, evaluating Synavive in patients with rheumatoid arthritis. The 12-week SYNERGY trial is fully enrolled with 259 patients with moderate to severe disease.
According to Zalicus, 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 after 12 weeks of treatment.
This represents a -0.9 change from baseline for Synavive, representing an improvement of about 17 percent, compared to a -0.5 change from baseline for placebo, which represents an improvement of about 10 percent.
However, the drug 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. Prednisolone is commonly-prescribed low-dose glucocorticoid.
Mark Corrigan, CEO of Zalicus, said, "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."
Corrigan added, "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."
Z160 is a novel, oral, N-type calcium channel blocker. Zalicus plans to initiate two phase 2a clinical trials with Z160 this year for the treatment of neuropathic pain, including post-herpetic neuralgia and neuropathic pain from lumbosacral radiculopathy, a form of chronic lower back pain.
Z944 is a novel, oral, T-type calcium channel blocker. A phase 1 multiple ascending dose clinical study with Z944 was initiated in July of this year, and is currently underway. I clinical development in the first quarter of 2013.
In Monday's regular session, ZLCS is trading at $1.04, down $0.35 or 25.18 percent on a volume of 5.09 million shares.
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by RTT Staff Writer
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