Zalicus Reports Top Line Phase 2b Trial Results with Synavive in Rheumatoid Arthritis
Achieves Primary Endpoint Compared to Placebo but Misses Key
Secondary Endpoint Compared to Prednisolone Alone Zalicus to Discontinue
Further Synavive Development
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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).
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.”
Study Design and Objectives
The Phase 2b clinical trial titled SYNERGY (SYNavivE for Reducing siGns
and sYmptoms of rheumatoid arthritis trial), was a 12-week, five-arm,
global, double-blind, placebo-controlled study designed to evaluate the
safety and efficacy of Synavive as a treatment for the signs and
symptoms of RA in subjects with moderate to severe disease. All study
subjects remained on stable dose DMARD therapy (e.g., methotrexate) in
the six weeks leading up to and during study participation. The trial
enrolled 259 subjects and was conducted in approximately 50 centers
throughout the United States, Europe and Latin America. The primary
objective of the trial was to evaluate Synavive efficacy compared to
placebo, while key additional secondary objectives included evaluating
the efficacy of Synavive compared to its individual components (2.7mg of
Prednisolone and 360mg of Dipyramidamole) as well as how Synavive
performed in comparison to 5mg of Prednisone, a commonly-prescribed
low-dose glucocorticoid. To learn more about the SYNERGY trial please
visit www.clinicaltrials.gov.
About Zalicus
Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain
and immuno-inflammatory diseases. Zalicus has a portfolio of proprietary
clinical-stage product candidates targeting pain and immuno-inflammatory
diseases, including Z160 and Z944, and have entered into multiple
revenue-generating collaborations with large pharmaceutical companies
relating to other products, product candidates and drug discovery
technologies. Zalicus applies its expertise in the discovery and
development of selective ion channel modulators and its combination high
throughput screening capabilities to discover innovative therapeutics
for itself and its collaborators in the areas of pain, inflammation,
oncology and infectious disease. To learn more about Zalicus, please
visit www.zalicus.com.
Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning Zalicus, its product candidates Synavive, Z160 and Z944,
their potential and its other business plans. These forward-looking
statements about future expectations, plans, objectives and prospects of
Zalicus may be identified by words like "believe," "expect," "may,"
"will," "should," "seek," “plan” or “could” and similar expressions and
involve significant risks, uncertainties and assumptions, including
risks related to the clinical development of Zalicus’s product
candidates, the unproven nature of the Zalicus cHTS drug discovery
technology, the Company's ability to obtain additional financing or
funding for its research and development and those other risks that can
be found in the "Risk Factors" section of Zalicus' annual report on Form
10-K on file with the Securities and Exchange Commission and the other
reports that Zalicus periodically files with the Securities and Exchange
Commission. Actual results may differ materially from those Zalicus
contemplated by these forward-looking statements. These forward-looking
statements reflect management’s current views and Zalicus does not
undertake to update any of these forward-looking statements to reflect a
change in its views or events or circumstances that occur after the date
of this release except as required by law.
