Zalicus Initiates the Second of Two Phase 2a Studies with Z160
- Highlights 2012 Accomplishments -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 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 candidate.
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 (PI-NRS).
"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.
2012 Accomplishments:
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.”
About Zalicus
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.
Forward-Looking Statements
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.
