- SEPIA-ACS Multiple-dose Phase II Results Showing 27- 42% Risk Reductionin ACS Complications Presented in Plenary Session of European Society ofCardiology Congress and Published in The Lancet
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Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that theinvestigational anti-Xa intravenous anticoagulant otamixaban reduced by 27 to42 percent the odds of the composite primary endpoint of death, myocardialinfarction, urgent revascularization or rescue GPIIb/IIIa use in 4 out of the5 otamixaban tested doses, versus standard UFH/eptifibatide combination in[non-ST] ACS patients suitable for invasive strategy. The results of theSEPIA-ACS1/ TIMI-42 were presented today at the plenary session of the AnnualEuropean Society of Cardiology congress in Barcelona and simultaneouslypublished online in The Lancet.
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Otamixaban is a first in class, rapid onset antithrombotic compound,acting as a direct selective inhibitor of factor Xa. Otamixaban isoriginating from Sanofi-aventis world-class thrombosis research portfolio andis currently in phase IIb clinical development phase.
"The data show that intermediate dosages of otamixaban may offersubstantial reduction in major coronary complications in patients presentingwith acute coronary syndrome, with bleeding rate comparable to currenttherapy," said Dr Marc Sabatine, MD, MPH, an Investigator in the TIMI StudyGroup and a cardiologist at Brigham and Women's Hospital, Harvard MedicalSchool. "This research is addressing an important medical need, bypotentially significantly improving outcomes of ACS patients undergoing PCIwhile simplifying the treatment pattern of the acute management phase of thedisease." he added.
The double-blind phase II SEPIA-ACS1/ TIMI-42 study randomized 3241patients from 36 countries in 6 treatment arms. The study assessed theefficacy and safety of five different doses of otamixaban versus the standardunfractionated heparin plus Glycoprotein IIb/IIIa inhibitor (eptifibatide),on background of standard dual antiplatelet therapy, in patients withhigh-risk non-ST-elevation acute coronary syndromes. SEPIA-ACS1 study showedthat otamixaban displayed clinically meaningful activity on the primaryendpoint 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 insufficientactivity, 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 approximately46 percent (p=0.0198) the risk of the composite of death or a secondmyocardial infarction, a predefined study secondary efficacy endpoint.
The potent antithrombotic effect of otamixaban was also accompanied witha dose-dependent bleeding profile. Combined intermediate otamixaban dosagesshowed a safety profile not statistically different with regard to TIMI majoror minor bleeding through 7 days, in comparison to UFH and GPIIb/IIIainhibitor 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 andmore effective treatment approach," said Marc Cluzel, MD Senior VicePresident Research and Development Sanofi-aventis. "We aim, on the basis ofthese findings to address through our development program remainingpatients', practionners' and payers' needs for management of ACS."
Acute Coronary Syndromes is a general term used to regroup clinicalsymptoms related to acute myocardial ischemia. ACS represents an area ofimportant medical need, as despite use of several antithrombotic therapies,death and myocardial infarction still occur in 5 to 8% of patients in thefollowing week after an initial event.
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