Study Shows Otamixaban Substantially Reduced Complications of Invasive Management of Acute Coronary Syndromes
– SEPIA-ACS Multiple-dose Phase II Results Showing 27- 42% Risk Reduction
in ACS Complications Presented in Plenary Session of European Society of
Cardiology Congress and Published in The Lancet
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the
investigational anti-Xa intravenous anticoagulant otamixaban reduced by 27 to
42 percent the odds of the composite primary endpoint of death, myocardial
infarction, urgent revascularization or rescue GPIIb/IIIa use in 4 out of the
5 otamixaban tested doses, versus standard UFH/eptifibatide combination in
[non-ST] ACS patients suitable for invasive strategy. The results of the
SEPIA-ACS1/ TIMI-42 were presented today at the plenary session of the Annual
European Society of Cardiology congress in
published online in The Lancet.
Otamixaban is a first in class, rapid onset antithrombotic compound,
acting as a direct selective inhibitor of factor Xa. Otamixaban is
originating from Sanofi-aventis world-class thrombosis research portfolio and
is currently in phase IIb clinical development phase.
“The data show that intermediate dosages of otamixaban may offer
substantial reduction in major coronary complications in patients presenting
with acute coronary syndrome, with bleeding rate comparable to current
therapy,” said Dr
Group and a cardiologist at Brigham and Women’s Hospital,
potentially significantly improving outcomes of ACS patients undergoing PCI
while simplifying the treatment pattern of the acute management phase of the
disease.” he added.
The double-blind phase II SEPIA-ACS1/ TIMI-42 study randomized 3241
patients from 36 countries in 6 treatment arms. The study assessed the
efficacy and safety of five different doses of otamixaban versus the standard
unfractionated heparin plus Glycoprotein IIb/IIIa inhibitor (eptifibatide),
on background of standard dual antiplatelet therapy, in patients with
high-risk non-ST-elevation acute coronary syndromes. SEPIA-ACS1 study showed
that otamixaban displayed clinically meaningful activity on the primary
endpoint from the threshold dose of 0.070 mg/kg/h, the second tested dose,
with a consistent antithrombotic effect up to the 5th highest tested dosage.
The lowest studied dosage was prematurely stopped due to insufficient
activity, based on recommendation by an independent data monitoring board.
Moreover a combined analysis of the intermediate doses (0.105 and 0.140
mg/kg/h) of otamixaban arms showed that otamixaban reduced by approximately
46 percent (p=0.0198) the risk of the composite of death or a second
myocardial infarction, a predefined study secondary efficacy endpoint.
The potent antithrombotic effect of otamixaban was also accompanied with
a dose-dependent bleeding profile. Combined intermediate otamixaban dosages
showed a safety profile not statistically different with regard to TIMI major
or minor bleeding through 7 days, in comparison to UFH and GPIIb/IIIa
inhibitor comparator (RR 1.20, 95% CI 0.64-2.27, p=0.5634).
“The SEPIA-ACS1 trial is providing very encouraging results for a new and
more effective treatment approach,” said
President Research and Development Sanofi-aventis. “We aim, on the basis of
these findings to address through our development program remaining
patients’, practionners’ and payers’ needs for management of ACS.”
Acute Coronary Syndromes is a general term used to regroup clinical
symptoms related to acute myocardial ischemia. ACS represents an area of
important medical need, as despite use of several antithrombotic therapies,
death and myocardial infarction still occur in 5 to 8% of patients in the
following week after an initial event.
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