Targanta Therapeutics Releases Results from Phase 2 SIMPLIFI Study Evaluating Single or Infrequent Doses of Oritavancin
22 October 2008 - 10:59PM
Business Wire
Targanta Therapeutics Corporation (Nasdaq: TARG) today announced
initial efficacy and safety results from its Phase 2 clinical study
investigating oritavancin at Single or Infrequent Doses for the
Treatment of Complicated Skin and Skin Structure Infections
(cSSSI), or SIMPLIFI. Results from this international, multi-center
study showed that single and infrequent doses of oritavancin were
equally as efficacious and safe as a three-to-seven day course of
therapy, the dosing regimen used in two Phase 3 clinical studies in
cSSSI caused by gram-positive pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA). SIMPLIFI Trial
Design SIMPLIFI was a Phase 2 randomized, double-blind, active
comparator study that enrolled patients with cSSSI, including MRSA.
SIMPLIFI measured clinical efficacy at test of cure (TOC) measured
at first follow-up on day 21. The study also examined the safety of
oritavancin in all patients as one of its secondary endpoints. 302
patients were randomized to one of three treatment arms for which
300 of the patients received either: 200 mg of oritavancin
intravenous (IV) daily for a minimum of three days and up to a
maximum of seven days; A single dose of 1200 mg of oritavancin IV;
or A single dose of 800 mg of oritavancin IV, with an optional
second dose of 400 mg IV given on day 5 at investigator discretion.
SIMPLIFI Trial Results Efficacy The primary efficacy endpoint, the
investigator defined clinical outcome (IDCO) in the clinically
evaluable (CE) population at TOC, was clinically and statistically
comparable across all 3 treatment groups. Secondary efficacy
endpoints were also comparable across the 3 treatment groups.
Population (N) � Investigator-Defined Clinical Outcome at TOC (%) �
Daily Dose 200 mg / Day for 3-7 Days � Single Dose 1200 mg (CI
90%)a � Infrequent Dose 800 mg Day 1 / 400 mg Day 5 (CI 90%)a
Intent to Treat (ITT) (300) � � 64.3 � 72.7 (-3.0, 17.7) � 66.0
(-10, 11.6) CE (228) � 72.4 � 81.5 (-2.5, 18.2) � 77.5 (-6.8, 15.4)
MRSA ME (82) � 73.9 � 74.3 (-18.8, 18.7) � 83.3 (-5.7, 28.0) aThe
90% confidence interval (CI) is based on estimated difference in
response rate between patients in the daily dose versus the single
dose or the infrequent dose using Mantel-Haenszel method stratified
by disease. Safety Data analysis determined that there were no
differences in overall safety in the incidence or the severity of
adverse events in the treatment population. The rates of
infusion-related adverse events were low in all groups and
comparable to those seen in the two Phase 3 clinical studies of
oritavancin in cSSSI. SIMPLIFI Safety � Dosing Arm � Daily Dose 200
mg / Day for 3-7 Days N=100 % � Single Dose 1200 mg N=99 % �
Infrequent Dose 800 mg Day 1 / 400 mg Day 5 N=103 %
Treatment-Emergent Adverse Events � 56.0 � 55.6 � 61.2 Serious
Adverse Events � 11.0 � 7.1 � 6.8 Mark Leuchtenberger, President
and CEO of Targanta, commented, �The data from SIMPLIFI Phase 2
confirms our belief that oritavancin has the potential to change
treatment paradigms in cSSSI by offering physicians flexibility in
treating patients. We are pleased that these results confirm the
pharmacokinetic profile of oritavancin which suggests that
oritavancin has the potential to be used safely and effectively
when given either as a single dose or as an infrequent dose for
cSSSI. We very much look forward to commencing a larger
confirmatory trial in 2009 that could demonstrate oritavancin�s
potential as the market�s first effective, single or infrequent IV
treatment of cSSSI caused by gram-positive bacteria.� 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 also is developing
an oral version of oritavancin for possible treatment of
Clostridium difficile infection. 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. 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, oritavancin having the potential to change treatment paradigms
in cSSSI by offering physicians flexibility in treating patients,
the pharmacokinetic profile of oritavancin suggesting its potential
to be used safely and effectively when given either as a single
dose or as an infrequent dose for cSSSI, commencement of a larger
confirmatory trial in 2009, and oritavancin�s potential as the
market�s first effective, single or infrequent IV 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.
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