Biocitech Park, Paris (France), December 4, 2009 - Endotis Pharma, the biopharmaceutical company
dedicated to the discovery and development of small-glyco drugs for applications in thrombosis and
oncology, today announced that Phase I clinical trial results for EP42675* will be presented on December
6, 2009 at the 51st Annual meeting of the American Society of Hematology congress (ASH) in New
Orleans, Louisiana, USA.
In May of this year, Endotis announced that EP42675 had successfully completed its Phase I program. In
October, the company then announced the initiation of a Phase I program with EP217609, the biotinylated
neutralizable form of EP42675, and its specific antidote, avidin.
EP42675 and EP217609 are the first representatives of a new class of synthetic, parenteral, antithrombotic
drugs with a dual mechanism of action combining the properties of an indirect factor Xa inhibitor and a
direct thrombin inhibitor. Furthermore, EP217609 can be neutralized within a few minutes by the
administration of avidin.
EP42675 was well tolerated in 100 healthy subjects enrolled in five Phase I studies, including single-dose
and multiple ascending dose trial designs and a pharmacodynamic interaction study with a combination of
oral aspirin and clopidogrel. Treatment with EP42675 resulted in dose-dependent increases in standard
and specific coagulation tests and a decrease in thrombin generation. EP42675 showed predictable
pharmacokinetic (PK) and pharmacodynamic (PD) profiles, with a low intra- and inter-subject variability.
In animals, the PK/PD profiles of EP217609 and EP42675 are similar.
On the basis of EP42675 data, an optimized Phase I program has been defined for EP217609, with a view
to quicker entry into Phase II in two target indications: extracorporeal circulation in cardiac surgery and
percutaneous coronary intervention in acute coronary syndromes.
The overall clinical development strategy for EP217609 and its antidote avidin has been endorsed by key
national Health Authorities throughout Europe and by the Food and Drug Administration in the USA.
Phase I results with EP217609 and avidin are expected in early 2010.
* EP42675, a new dual-action anticoagulant: pharmacodynamic and pharmacokinetic profile, and
interactions with acetylsalicylic acid, clopidogrel, and unfractionated heparin. Pierre Gueret, Chantal
Krezel, Paul van Giersbergen, Eliane Fuseau, Thierry Lamy and Eric Neuhart.
About Endotis Pharma (www.endotis.com)
Endotis Pharma is a biopharmaceutical company dedicated to the discovery and development of small-glyco drugs
(heparin/heparan sulfate mimetics) in thrombosis, oncology and a range of other indications. The value of this
platform has been demonstrated by Endotis' breakthrough thrombosis franchise of parenteral and oral drugs in
clinical and preclinical development and a promising oncology pipeline. Endotis has 35 employees based in Paris
and Lille (France).
Disclaimer: The development of new drug technologies is difficult, erratic and unpredictable. Endotis Pharma’s forecasts and
future economic performance depend on research that has yet to be performed and on a number of other factors. The company's
future economic performance may differ significantly from that currently forecast.
For more information:
Press contact: Alize RP
+33 (0)6 64 18 99 59
+ 33 (0)1 41 22 07 32
Investor contact: Endotis Pharma
Charles Woler, Chairman and CEO
Stéphane Degove, Head of Finance
+33 (0)1 48 46 84 87