Zalicus Initiates the First of Two Phase 2a Studies with Z160, a First-in-Class, Oral, State-Dependent, Selective N-type Calcium Channel Blocker, for the Treatment of Chronic Neuropathic Pain
First Study to Focus on Lumbosacral Radiculopathy, chronic
neuropathic pain originating from the spine
Second Phase 2a Clinical Trial Planned to Initiate Fourth Quarter 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 4, 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 that it has initiated the
first of two Phase 2a clinical studies with Z160, its first-in-class,
oral, state-dependent, selective N-type calcium channel blocker for the
treatment of chronic neuropathic pain indications. This first Phase 2a
study will enroll subjects with chronic neuropathic pain associated with
Lumbosacral Radiculopathy (LSR). 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 prevalence of LSR is
high, affecting 3-5% of the global population1. Currently
there are no drug treatments specifically approved to treat this common
condition, indicating that LSR is a condition with very high unmet
medical need.
Z160 is a state-dependent modulator of the N-type (Cav2.2) calcium
channel designed to selectively modulate only those neurons transmitting
pain, specifically neurons that are undergoing high-frequency firing.
Z160 demonstrated efficacy in several animal models of neuropathic pain.
Additionally, phase 1 clinical trials have established Z160 as a very
safe and tolerable drug candidate.
A second Phase 2a neuropathic pain clinical study, which is planned to
initiate in the fourth quarter of 2012, will evaluate Z160 for the
treatment of Postherpetic Neuralgia (PHN), a painful neuropathic
condition resulting from an outbreak of the herpes zoster virus,
otherwise known as shingles. Top line data for both studies is expected
to be available late in the second half of 2013.
"We are excited to move Z160, with its novel mechanism of action,
forward into Phase 2a human clinical testing this year," 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."
Study Design and Objectives
The Z160 Phase 2a Lumbosacral Radiculopathy (LSR) clinical trial is a
6-week, double-blind, multi-center, randomized, placebo-controlled study
designed to evaluate the safety and efficacy of Z160 as a treatment in
reducing the neuropathic pain of subjects with the condition. The trial
is expected to enroll up to approximately 140 subjects and will be
conducted in approximately 20 centers throughout the United States. The
primary objective of the trial is to evaluate Z160 efficacy compared to
placebo in reducing pain in subjects with LSR as measured by change in
average daily pain score from baseline to week 6 of treatment based on
an 11-point Pain Intensity Numeral Rating Scale (PI-NRS). To learn more
about this trial please visit www.clinicaltrials.gov.
About Z160 and N-type Calcium Channel Blockers
Z160 is a first in class, oral, state dependent, selective N-type
calcium channel (Cav 2.2) blocker. Z160 has demonstrated efficacy in
multiple animal models of neuropathic and inflammatory pain, suggesting
that Z160 has the potential to treat a broad range of chronic pain
conditions. In addition, Z160 was well tolerated in previously conducted
clinical trials involving over 200 subjects. 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 has utilized its expertise in this field to successfully
discover high affinity, selective and orally available compounds, such
as Z160, that show promise for further development as therapies for pain.
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 such as Synavive®, 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.
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
Zalicus’ plans for its clinical development. These forward-looking
statements about future expectations, plans, objectives and prospects of
Zalicus and Z160 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
Z160, the unproven nature of the Zalicus Ion channel 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.
