Eurostars Project E!10859 DOAC-STOP: A novel inhibitor to prevent uncontrolled bleedings in anticoagulant users
|Coordinator||Adlego Biomedical AB|
|Funding from Vinnova||SEK 0|
|Project duration||April 2017 - March 2019|
Purpose and goal
DOAC-STOP aims to develop PseudoXa, a biological for the instantaneous restoration of blood clotting activity in patients with major bleedings as a result of blood thinners.
Expected results and effects
PseudoXa will be produced and the preclinical efficacy, pharmacokinetics (PK), and toxicity (TOX) of PseudoXa will be determined in vitro and in vivo. The end result will be a completed preclinical study dossier for PseudoXa. After the project, clinical phase development will be initiated.
Planned approach and implementation
WP2: Focuses on developing research models, identifying read-out parameters, and setting up analytical techniques for efficacy, PK, and toxicity studies on biologicals that act on the coagulation cascade. WP4: The PK and PD properties of PseudoXa will be assessed to evaluate the biological and physiological characteristics of PseudoXa. WP5: Repeated dose toxicity studies will ´cover´ for the intended duration of the clinical studies. Furthermore, the duration of the toxicology study will be in line with mostly used duration of toxicology studies.