Zalicus Completes Patient Enrollment in Two Phase 2 Clinical Studies of Z160
for Chronic Neuropathic Pain
Top-line Data for Both Lumbosacral Radiculopathy and Postherpetic Neuralgia
Expected in the Fourth Quarter of 2013
CAMBRIDGE, Mass. -- September 3, 2013
Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain,
today announced that it has completed patient enrollment in two Phase 2
clinical studies of Z160 for chronic neuropathic pain indications including
lumbosacral radiculopathy and postherpetic neuralgia. Top-line results of both
studies are expected in the fourth quarter of 2013. Z160 is a first-in-class,
oral, state-dependent, selective N-type calcium channel (Cav 2.2) blocker in
development for chronic neuropathic pain.
Lumbosacral radiculopathy (LSR) is a common neuropathic pain condition
resulting from the compression or irritation of the nerve roots exiting the
lumbar region of the spine. Common symptoms include pain radiating from the
lower back and down the legs, as well as numbness and tingling in the lower
extremities. The randomized, double-blind, placebo controlled clinical study,
evaluating Z160 as compared to placebo in approximately 140 subjects in 25
clinical sites in the United States, was initiated in the third quarter of
2012. The primary efficacy endpoint for this study is the change in weekly
pain scores on a numerical rating scale. Other endpoints include multiple
other pain, functional and safety measures.
Postherpetic neuralgia (PHN) is a painful neuropathic condition resulting from
an outbreak of the herpes zoster virus, otherwise known as shingles. The
randomized, double-blind, placebo controlled clinical study, evaluating Z160
as compared to placebo in approximately 140 subjects in 55 clinical sites in
the United States, was initiated in the fourth quarter of 2012. The primary
efficacy endpoint for this study is the change in weekly mean pain scores on a
numerical rating scale. Other endpoints include multiple other pain,
functional and safety measures.
"We are pleased with how efficiently these trials have been conducted and look
forward to evaluating and reporting the activity of Z160, with its novel
mechanism of action, in chronic neuropathic pain," commented Mark H.N.
Corrigan, MD, President and CEO of Zalicus. “While there are a few treatments
currently approved for chronic neuropathic pain, there still exists a
significant unmet medical need for a more targeted and efficacious therapy
with an improved safety and tolerability profile. “
Zalicus is currently advancing Z160, a first-in-class, oral, state-dependent,
selective N-type calcium channel (Cav 2.2) blocker, through Phase 2a clinical
development in chronic neuropathic pain. Z160 is designed to selectively
target neuronal pain signaling by modulating neurons that are undergoing
high-frequency firing. Z160 has demonstrated efficacy in multiple animal
models of neuropathic and inflammatory pain, suggesting that it has the
potential to treat a broad range of chronic pain conditions. Additionally,
clinical trials in over 200 subjects have established Z160 as a safe and well
tolerated drug candidate. N-type calcium channels have been recognized as key
targets in controlling pain because of their key role in transmitting pain
through the spinal nerves to the brain.
Zalicus Inc. (Nasdaq Capital Market: ZLCS) is a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain.
Zalicus has a portfolio of proprietary clinical-stage product candidates
targeting pain such as Z160 and Z944 and has 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.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its
product candidate Z160, its potential and the plans for its clinical
development, the Zalicus selective Ion channel modulation technology and
related preclinical product candidates and Zalicus’s other business plans.
These forward-looking statements about future expectations, plans, objectives
and prospects of Zalicus and its product candidates 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 development and regulatory
approval of Zalicus’ product candidates, including risks relating to
formulation and clinical development of Z160, the ability of Zalicus to
initiate and successfully complete clinical trials of its product candidates,
the unproven nature of the Zalicus drug discovery technologies, 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.
(c) 2013 Zalicus Inc. All rights reserved.
Justin Renz, 617-301-7575
Gina Nugent, 617-460-3579
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