Zalicus Initiates the Second of Two Phase 2a Studies with Z160
- Highlights 2012 Accomplishments -
CAMBRIDGE, Mass. -- January 3, 2013
Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and
develops novel treatments for patients suffering from pain, today announced
that it has initiated the second of two Phase 2a clinical studies with Z160,
its first-in-class, oral, state-dependent, selective N-type (Cav2.2) calcium
channel blocker for the potential treatment of chronic neuropathic pain. The
Company also provided an overview of 2012 accomplishments.
Z160 is designed to selectively target neuronal pain signaling by modulating
neurons that are undergoing high-frequency firing. Z160 has demonstrated
efficacy in several animal models of neuropathic pain, and clinical trials in
over 200 subjects have established Z160 as a safe and well tolerated drug
The second Phase 2a study with Z160 is enrolling subjects with Postherpetic
Neuralgia (PHN), a chronic neuropathic pain state resulting from an outbreak
of the herpes zoster virus, otherwise known as shingles. Due to this prolonged
neuropathic pain, PHN is an industry-accepted standard condition for
establishing clinical proof-of-concept for pharmaceutical product candidates
seeking to address neuropathic pain. The 6-week, double-blind, multi-center,
randomized, placebo-controlled study is expected to enroll approximately 140
subjects and will be conducted in approximately 35 centers throughout the
United States. The primary objective of the trial is to evaluate the efficacy
of Z160 compared to placebo in reducing pain in subjects with PHN as measured
by the change in average weekly pain score from baseline to week 6 of
treatment based on a daily 11-point Pain Intensity Numeral Rating Scale
"Postherpetic Neuralgia is an important medical condition for evaluating the
activity of Z160 for three important reasons. First, it is a well-recognized
standard for establishing clinical proof of concept in neuropathic pain;
second, with a prevalence of less than 200,000 patients in the U.S., it has
the potential for orphan drug status and could be a feasible first indication
to pursue from a commercial perspective; and third, significant unmet medical
need exists for novel, targeted and more efficacious chronic neuropathic pain
therapies with improved safety and tolerability profiles such as Z160,”
commented Mark H.N. Corrigan, MD, President and CEO of Zalicus.
The first Phase 2a clinical study with Z160, which began enrolling patients in
August of 2012, is evaluating the activity of Z160 in subjects with pain
associated with Lumbosacral Radiculopathy, a chronic neuropathic pain
condition resulting from the compression or irritation of the nerve roots
exiting the lumbar region of the spine.
*Z160. Advanced Z160, a first-in-class, oral, state dependent, selective
N-type calcium channel (Cav 2.2) blocker into two Phase 2a clinical trials
for neuropathic pain including lumbosacral radiculopathy (LSR) which began
in the third quarter of 2012 and postherpetic neuralgia which began in the
fourth quarter of 2012. Top line data from both studies are expected to be
available late in the second half of 2013.
*Z944. Completed Phase 1 single and multiple ascending dose clinical
studies with Z944 and are consulting with regulatory authorities on the
clinical path forward. Z944 is a novel, oral, T-type calcium channel
blocker which has demonstrated efficacy in a number of preclinical
inflammatory pain models and other disease models. T-type calcium channels
have been recognized as key targets for therapeutic intervention in a
broad range of cell functions and have been implicated in pain signaling.
*Sodium Channel Blockers. Working to discover novel, oral, selective,
state-dependent sodium channel blockers. Sodium channel blockers are a
promising target linked to chronic pain.
*Exalgo. A 32mg dosage strength of Exalgo was approved by the FDA in August
2012. We have received over $7.9 million in royalty revenue on Exalgo
sales through the quarter ended September 30, 2012.
*Prednisporin. Sanofi announced its intention to continue Prednisporin
development under a third party sublicense. Future potential milestone
payments and royalties to Zalicus will remain in place.
*cHTS. Our combination drug discovery research services business on track
to generate approximately $7.0 million of revenue in 2012.
“During 2012, we made a number of advances with our novel ion channel
programs, including advancing our novel formulation of Z160 into Phase 2
clinical development and advancing Z944 into the clinic,” commented Mark H.N.
Corrigan, MD, President and CEO of Zalicus. “We plan to build on this success
in 2013 by generating proof-of-concept data for Z160 in multiple indications
and seeking to advance the development of our other ion channel programs.”
Zalicus Inc. (Nasdaq: 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 candidates, their potential and the plans for their clinical and
preclinical development, the Zalicus selective Ion channel modulation
technology and related preclinical product candidates, Zalicus’ combination
drug discovery technology, cHTS, and its financial condition, results of
operations, and 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 sale and
marketing of Exalgo by Covidien, risks related to the development and
regulatory approval of Zalicus’ product candidates, including risks relating
to formulation and clinical development of Z160 and Z944, the unproven nature
of the Zalicus drug discovery technologies, the ability of the Company or its
collaboration partners to initiate and successfully complete clinical trials
of its product candidates, 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.
Justin Renz, 617-301-7575
Gina Nugent, 617-460-3579
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