Amediplase should therefore be an elective drug for early thrombolyisis (even in a pre-hospital setting) with dosing tailored to each single patient, and hence with a reduced risk of severe bleeding as side effects.

Amediplase is the outcome of a Menarini project aimed to identify and develop a newer thrombolytic agent characterized by potent fibrinolytic activity, enhanced selectivity for the thrombus (fibrin-specificity), prolonged plasma half-life, absence of immunogenicity and also a convenient manufacturing cost. Amediplase should be used as a single bolus administration and it will allow a weight and age-adjusted regimen.

Amediplase is a glycosylated 356 aminoacid protein. It is an hybrid molecule conjugating portions of two natural molecules: t-PA (tissue plasminogen activator) and sc-UPA (single chain urokinase). Amediplase includes the kringle 2 of t-PA (conferring the fibrin-specificity) and the catalytic moiety of sc-UPA (conferring the fibrinolytic properties and resistance to inhibitors). The fusion point in the molecule is selected in a way to protect the drug from proteolysis by thrombin or other proteases.

Ready to enter the phase III clinical trial for the potential treatment of acute myocardial infarction.

 

 

Phase III