Cubist Submits Clinical Trial Application to Initiate First-in-Human Study of CB-618—A Beta-Lactamase Inhibitor Discovered ...
January 10 2014 - 11:05AM
Business Wire
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that
it submitted a Clinical Trial Application (CTA) to the Dutch
Competent Authority and Ethics Committee to initiate a
first-in-human study of CB-618 in the Netherlands. Discovered by
Cubist, CB-618 is a novel, broad-spectrum beta-lactamase inhibitor
(BLI) investigational compound. Based on in vitro studies, CB-618
has been shown to increase the spectrum of activity of certain
beta-lactam antibiotics. (Beta-lactamases are enzymes produced by
some bacteria that provide resistance to certain beta-lactam
antibiotics.)
If approved by the Dutch Competent Authority and Ethics
Committee, Cubist plans to conduct the proposed initial study
during the first half of 2014. The purpose of the proposed study
will be to evaluate the safety, tolerability and pharmacokinetics
of CB-618 administered as single and multiple doses. The overall
goal of the CB-618 development program is to enhance the spectrum
of activity of beta-lactam antibiotics against resistant pathogens.
CB-618 is part of a platform research approach by Cubist to
identify new BLIs, which could potentially restore and expand the
clinical utility of certain existing antibiotics. CB-618 is a
product of research and development efforts at Cubist to combat
multidrug resistance in Gram-negative pathogens.
“We are excited to announce a new compound discovered at Cubist
which has the potential to address unmet medical needs. If
successful, CB-618 could help combat resistance to certain
beta-lactam antibiotics and serious infections, such as those
caused by carbapenem-resistant bacteria, including CRE, and other
resistant pathogens, which are a growing threat globally,” said
Steven Gilman, Ph.D., Executive Vice President of Research and
Development and Chief Scientific Officer of Cubist Pharmaceuticals.
“We look forward to working with global regulatory authorities on
pathways to advance into the clinic and potentially streamline
development of this beta-lactamase inhibitor.”
The filing of clinical trial and investigational new drug
applications from the Company’s own discovery efforts is part of
Cubist’s five-year strategic goals – Building Blocks of Growth –
announced in 2012. Cubist is taking a comprehensive approach to the
discovery of new antibiotics to treat serious bacterial infections,
from blocking resistance mechanisms, such as with CB-618, that
inactivate otherwise effective antibiotics to the discovery of new
classes of antibacterials from natural product and medicinal
chemistry-driven approaches. The Building Blocks of Growth are
intended to help Cubist build on its momentum to deliver new
medicines to patients and drive long-term value for its customers
and shareholders.
About CB-618
Beta-lactamases are enzymes used by Gram-negative bacteria as
the predominant mechanism of resistance to beta-lactam antibiotics.
The spread of extended-spectrum β-lactamases (ESBLs), AmpC
beta-lactamases and carbapenemases, especially in the
Enterobacteriaceae, is a threat to the utility of various
beta-lactam antibiotics. Discovered by Cubist, CB-618 is a novel,
broad-spectrum beta-lactamase inhibitor (BLI) investigational
compound. CB-618 has been shown, in pre-clinical studies, to
increase the spectrum of activity of beta-lactam antibiotics to
include isolates known to produce carbapenemases, including in
Enterobacteriaceae (such as carbapenem-resistant and
carbapenemase-producing Enterobacteriaceae – CRE and CPE),
Klebsiella pneumoniae carbapenemases (KPCs) and OXA-48, as well as
ESBLs and AmpC beta-lactamases.
About Cubist
Cubist Pharmaceuticals, Inc. is a global biopharmaceutical
company focused on the research, development, and commercialization
of pharmaceutical products that address significant unmet medical
needs in the acute care environment. Cubist is headquartered in
Lexington, Massachusetts, with a central international office
located in Zurich, Switzerland. Additional information can be found
at Cubist’s web site at www.cubist.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws. Any statements contained herein
which do not describe historical facts, including but not limited
to, statements regarding: the development of CB-618, including the
expected timing for commencing clinical studies and regarding
engaging in discussions with global regulatory authorities
regarding the development of CB-618; the therapeutic potential of
CB-618; our research efforts, including our efforts to identify new
BLIs for use with existing antibiotics and to discover new
antibacterials; and our five-year Building Blocks of Growth
strategic goals, are forward-looking statements which involve risks
and uncertainties that could cause actual results to differ
materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others: the risk that
the Dutch Competent Authority and Ethics Committee may not approve
our CTA for CB-618; the fact that drug discovery and development is
complex, time consuming, expensive, fraught with a high rate of
failure and success in pre-clinical or early stage clinical trials
does not mean that later stage trials will be successful; the
timing and feasibility of any subsequent trials is dependent on our
ability to successfully work with regulatory authorities on the
design of the trials, among other things; clinical trials of CB-618
may produce negative or inconclusive results; we may experience
delays in the commencement, enrollment, completion or analysis of
clinical testing for CB-618, or significant issues regarding the
adequacy of our clinical trial designs or the execution of our
clinical trials, which could result in increased costs and delays,
or limit our ability to obtain regulatory approval; the third
parties upon whom we rely to conduct our clinical trials may not
perform as expected; CB-618 may not receive regulatory approval or
be successfully commercialized; our ability to maintain and enforce
intellectual property protection for CB-618; competitive risks from
current and future therapeutic alternatives to CB-618; technical
difficulties or excessive costs relating to the manufacture or
supply of CB-618, including our ability to work with and the
performance of our third party contract manufacturers that we rely
on to manufacture and supply CB-618; we may encounter other
unanticipated or unexpected risks with respect to the development
or manufacture of CB-618; our ability to achieve our Building
Blocks of Growth long-range goals, including as a result of our
ability to continue to grow revenues from the sale of CUBICIN®,
DIFICID® and ENTEREG®, generic and other competition, manufacturing
issues, our ability to successfully develop, gain marketing
approval for and commercially launch our product candidates for
their planned indications and on their expected timelines, and our
ability to discover, in-license or acquire new products and product
candidates; and those additional factors discussed in our most
recent annual report on Form 10-K and quarterly report on Form 10-Q
filed with the Securities and Exchange Commission. We caution
investors not to place considerable reliance on the forward-looking
statements contained in this press release. These forward-looking
statements speak only as of the date of this document, and we
undertake no obligation to update or revise any of these
statements.
INVESTORS:Cubist Pharmaceuticals,
Inc.Eileen C. McIntyre, 781-860-8533Vice President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:US Media:Cubist Pharmaceuticals,
Inc.Jennifer Baird, 781-860-1282Director of Product
Communicationsjennifer.baird@cubist.comorEurope Media:Weber
ShandwickCaroline Maddock, +44 (0) 207 067 0226Deputy Managing
Director, Healthcmaddock@webershandwick.com