Synthetic oligosaccharide that is an indirect factor Xa inhibitor is expected to enter Phase I next year.

Endotis Pharma and Catalent Pharma Solutions forged an alliance to develop oral formulations of synthetic oligosaccharide (small-glyco) drugs. The initial focus will be on development of Endotis’ oral anticoagulant, EP37151.

The drug, which acts as an indirect factor Xa inhibitor, is expected to start Phase I development during the second quarter of next year. The companies say that other oral anticoagulants are also expected to join their pipeline next year.

The collaboration will exploit Endotis’ expertise in synthetic oligosacchariade drug discovery and Catalent’s oral drug formulation and drug manufacturing capabilities. “The technology developed by Catalent is a major step forward for Endotis and will unlock therapeutic indications for our small-glyco drugs in thrombosis and other therapeutic areas,” states Charles Woler, Endotis’ chairman and CEO. 

With specialist expertise in drug delivery and formulation, Catalent Pharma Solutions offers a range of product development services including API development, preclinical/clinical support, analytical, clinical manufacturing, and regulatory consulting. The company was formed in April 2007, when financial advisory firm Blackstone Group acquired the Pharmaceutical Technologies and Services segment of Cardinal Health.

Endotis Pharma specializes in the discovery and development of synthetic oligosaccharide drugs against thrombosis and cancer. In October the company started a Phase I program with EP217609, a first-in-class synthetic neutralizable anticoagulant, and its specific antidote, avidin. The company concurrently sealed a manufacturing and co-development agreement for avidin with Tecnogen, part of the Sigma-Tau Group.

EP217609 is a synthetic parenteral anticoagulant in development for intravenous or subcutaneous adminsitration at fixed dose without the need for monitoring. The company claims the drug has a dual mode of action that combines indirect factor Xa inhibition with direct thrombin inhibition. EP217609 can also be neutralized within a few minutes by administering the antidote, avidin.

EP217609 is the biotinylated form of EP42675, which in May successfully completed a Phase I study in 100 healthy subjects. Based on EP42675 data, an optimized Phase I trial has been defined for EP217609, which will allow a quicker entry into Phase II in two target indications: extracorporeal circulation (ECC) in cardiac surgery and percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS).

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