Endotis Pharma presents Phase I clinical trial results for a first-in-class synthetic parenteral neutralizable anticoagulant

09-Jul-2010 - France

Endotis Pharma announced that Phase I clinical trial results for EP217609 were presented at the 21st International Congress on thrombosis (ICT) in Milan, Italy. EP217609 is a first-in-class synthetic, parenteral anticoagulant which can be neutralized by a specific antidote, avidin. EP217609 has a dual mechanism of action, which combines direct free and clot-bound thrombin inhibition and indirect factor Xa inhibition.

In this first Phase I study, EP217609 was well tolerated in 24 healthy subjects exposed to single, ascending doses. As expected, administration of EP217609 resulted in dose-dependent increases in standard and specific coagulation tests and, a decrease in thrombin generation. EP217609 pharmacodynamic and pharmacokinetic profiles were predictable, with low inter-subject variability.

Eric Neuhart, MD, Head of Clinical Research and Development at Endotis Pharma commented: “EP217609 and its specific antidote avidin are being developed in patients undergoing cardiac surgery. These drugs could represent the first alternative to unfractionated heparin and its antidote protamine which, despite their known limitations and side effects, have been used for more than 50 years during cardiopulmonary bypass and extracorporeal circulation. Following positive results of two separate first-in-man studies with EP217609, and avidin, Endotis has initiated an additional Phase I study for assessing EP217609 neutralization by avidin in healthy subjects.”

Dr Eric Neuhart added: “Along with ongoing preclinical pharmacology studies3, these Phase I clinical studies with EP217609 and avidin represent key steps towards developing the two drugs in high-risk patients undergoing cardiac surgery.

https://www.bionity.com/en/news/119899/endotis-pharma-presents-phase-i-clinical-trial-results-for-a-first-in-class-synthetic-parenteral-neutralizable-anticoagulant.html