Endotis Pharma reports successful completion of the neutralization study of the anticoagulant EP217609 by avidin

17-Nov-2010 - France

Endotis Pharma announced that it has successfully completed the first study assessing in healthy subjects the Neutralization of the anticoagulant EP217609 by its specific antidote avidin. EP217609 and avidin were well tolerated in the 36 healthy subjects enrolled in this study. A single intravenous bolus of EP217609 achieved a stable anticoagulation during 90 minutes, then the subsequent administration of avidin triggered a rapid, complete, and irreversible neutralization of the anticoagulant activity of EP217609 without rebound effects. EP217609 is a first-in-class synthetic, parenteral anticoagulant that can be neutralized by a specific antidote avidin (EP5001). EP217609 has a dual mechanism of action combining direct (free and clot-bound) thrombin inhibition and indirect factor Xa inhibition. Eric Neuhart, MD, Head of Clinical Research and Development at Endotis Pharma, commented: “This study confirms the data generated in previous studies performed in healthy subject and animals. EP217609 and avidin have a predictable and reproducible pharmacodynamic and pharmacokinetic profile with a low inter-subject variability. ” Eric Neuhart added: "EP217609 and avidin will be developed in extracorporeal circulation for cardiac surgery as a first indication. EP217609 and avidin could represent the first alternative to replace heparin and its antidote protamine, used for more than 50 years in cardiac surgery despite their limitations and side effects. The data generated during phase I clinical studies will allow the optimization of the phase II clinical program that will be initiated in cardiac surgery patients in the first half of 2011."

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