Targanta Therapeutics Announces Positive Top-Line Results from Oritavancin Phase 2 SIMPLIFI Trial
September 02 2008 - 6:58AM
Business Wire
Targanta Therapeutics Corporation (Nasdaq: TARG) today announced
positive top-line results from a Phase 2 clinical trial
investigating the efficacy and safety of oritavancin at Single or
Infrequent Doses for the Treatment of Complicated Skin and Skin
Structure Infections (cSSSI), or SIMPLIFI. Oritavancin is
Targanta�s lead antibiotic candidate targeting gram-positive
organisms, including methicillin-resistant Staphylococcus aureus,
or MRSA. Oritavancin, administered in a single or in an infrequent
dosing regimen, demonstrated comparable efficacy and safety to a
three-to-seven day course of oritavancin therapy, as administered
in two previously conducted Phase 3 clinical trials for the
treatment of cSSSI. Each of these Phase 3 clinical trials met their
primary endpoint. These top-line efficacy results from SIMPLIFI are
consistent with Targanta�s previously published preclinical
studies. The SIMPLIFI trial was designed based on oritavancin�s
unique pharmacokinetic profile and demonstrated
concentration-dependent bactericidal activity. Mark Leuchtenberger,
President and CEO of Targanta, commented, �We believe the potential
to cure cSSSI with just a single or infrequent dosing regimen could
make oritavancin the go-to drug of choice among physicians who are
seeking an effective and convenient weapon for their antibiotic
armamentarium, and thereby lead to a shift in the treatment
paradigm for gram-positive infections. With the SIMPLIFI results in
hand, we will begin to design a larger confirmatory trial that
could demonstrate oritavancin�s potential as the market�s first
effective single or infrequent intravenous (IV) treatment of cSSSI
caused by gram-positive bacteria.� Results of the Phase 2 SIMPLIFI
trial will be used to design a Phase 3 study to assess the benefits
and risks of a single-dose regimen for the treatment of cSSSI.
Targanta expects full data from SIMPLIFI will be presented prior to
the end of the year. About SIMPLIFI The Phase 2 SIMPLIFI trial was
an international, multi-center, randomized, double-blind,
controlled study of approximately 300 patients with cSSSI,
including MRSA. SIMPLIFI measured clinical response to oritavancin
(either cure or improvement versus failure) at the first follow-up
visit (Test of Cure) in clinically evaluable patients as its
primary endpoint. The study examined the safety of oritavancin in
all intent-to-treat patients as its secondary endpoint. Additional
details about the SIMPLIFI trial design can be found in a press
release dated May 20, 2008, �Targanta Completes Enrollment in Phase
2 Oritavancin Infrequent Dosing Study,� found on the Investor
Relations section of Targanta�s website at
www.targanta.com/investors/newsrelease.html. About Oritavancin
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic
candidate with potent bactericidal (killing) activity against a
broad spectrum of gram-positive bacteria. In its intravenous (IV)
formulation, the product candidate has been tested in over 2,400
individuals and has completed two Phase 3 studies for the treatment
of complicated skin and skin structure infections (cSSSI) in which
the primary endpoints were met. Targanta submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) in
February 2008 seeking to commercialize oritavancin for the
treatment of cSSSI; the FDA accepted the NDA submission for
standard review, establishing an action date of December 8, 2008.
Targanta�s Marketing Authorization Application (MAA) for
oritavancin was accepted for review by the European Medicines
Agency (EMEA) in June 2008. Targanta is also developing an oral
version of oritavancin for the possible treatment of Clostridium
difficile-related conditions. About Targanta Therapeutics Targanta
Therapeutics Corporation (Nasdaq: TARG) is a biopharmaceutical
company focused on developing and commercializing innovative
antibiotics to treat serious infections in the hospital and other
institutional settings. The Company�s pipeline includes an
intravenous version of oritavancin, a semi-synthetic
lipoglycopeptide antibiotic currently awaiting U.S. and EU
regulatory approval, and, a program to develop an oral version of
oritavancin for the treatment of Clostridium difficile. The Company
has operations in Cambridge, MA, Indianapolis, IN, and Montreal,
Qu�bec, Canada. For more information on Targanta, visit
www.targanta.com. Safe Harbor Statement This press release contains
�forward-looking statements� that are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These are statements that are predictive in nature, that
depend upon or refer to future events or conditions or that include
words such as �potential,� �may,� "will," "expects," "projects,"
"anticipates," "estimates," "believes," "intends," "plans,"
"should," "seeks," �hope� and similar expressions. Such statements
include, but are not limited to the potential to cure cSSSI with
just a single or infrequent dosing regimen of oritavancin;
oritavancin becoming the antibiotic drug of choice among
physicians; and oritavancin�s potential as the market�s first
effective, single or infrequent intravenous (IV) infusion for
treatment of cSSSI caused by gram-positive bacteria.
Forward-looking statements involve known and unknown risks and
uncertainties that may cause actual future results to differ
materially from those projected or contemplated in the
forward-looking statements. Forward-looking statements may be
significantly impacted by certain risks and uncertainties described
in Targanta�s filings with the Securities and Exchange Commission.
The risks and uncertainties referred to above include, but are not
limited to, delays in obtaining or a failure to obtain regulatory
approval for Targanta�s product candidates; unfavorable clinical
trial results; Targanta�s potential inability to initiate and
complete pre-clinical studies and clinical trials for its product
candidates; the possibility that results of pre-clinical studies
are not necessarily predictive of clinical trial results; and those
other risk factors that are described more fully in the Company�s
filings with the Securities and Exchange Commission. Targanta does
not undertake any obligation 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.
Targanta Therapeutics Corp (MM) (NASDAQ:TARG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Targanta Therapeutics Corp (MM) (NASDAQ:TARG)
Historical Stock Chart
From Jul 2023 to Jul 2024