Endotis reports the successful completion of Phase I clinical trials of neutralizable anticoagulant EP217609 and antidote avidin
Endotis Pharma announced that the neutralizable anticoagulant EP217609 and its specific antidote avidin have successfully completed their respective first-in-man Phase I clinical trials.
EP217609 is a first-in-class synthetic, parenteral anticoagulant which can be neutralized with a specific antidote (avidin - an egg-derived protein). It has a dual mechanism of action which combines indirect factor Xa inhibition and direct thrombin inhibition. EP217609 is the neutralizable version of EP42675, which has already successfully completed a Phase I program in 108 healthy subjects.
EP217609 was well tolerated in 24 healthy subjects exposed to single, ascending doses. As expected, administration of the EP217609 anticoagulant resulted in dose-dependent increases in standard and specific coagulation tests, whereas a decrease in thrombin generation was observed. EP217609 ‘s pharmacodynamic and pharmacokinetic profiles were predictable, with low inter-subject variability. In a separate trial, avidin was well tolerated in 24 healthy subjects exposed to single, ascending doses. There was no evidence of hypersensitivity reactions.
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