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news.Results demonstrate, Otamixaban substantially reduced complications of invasive management of acute coronary syndromes
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Sanofi-aventis’ anti-Xa intravenous anticoagulant otamixaban has reduced by 27 to 42% 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 ACS patients suitable for invasive strategy.
Otamixaban is an 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 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 0.070mg/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 based on recommendation by an independent data monitoring board. Moreover a combined analysis of the intermediate doses (0.105 and 0.140mg/kg/h) of otamixaban arms showed that otamixaban reduced by approximately 46% (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).
Marc Cluzel, senior vice president of research and development at Sanofi-aventis, said: “The SEPIA-ACS1 trial is providing very encouraging results for a new and more effective treatment approach. We aim, on the basis of these findings to address through our development program remaining patients’, practionners’ and payers’ needs for management of ACS.”