The study is being conducted in patients with stable angina undergoing percutaneous coronary intervention (PCI). The objectives of the Phase Ib study are to determine safety and tolerance when adding ALX-0081 to a standard anti-thrombotic regimen in patients undergoing PCI and to document biological and clinical response to the therapy. The company intends to recruit up to 64 patients with stable angina for the study.
Dosing regimes relevant for the treatment of acute coronary syndrome patients will be evaluated in this multiple dose study, based on the pharmacokinetic, pharmacodynamic and safety data obtained from the first study, in order to establish the biologically effective dose for ALX-0081.
Ablynx is also expanding its anti-thrombotic portfolio by developing ALX-0681, also targeting vWF, a subcutaneously administered Nanobody designed to access additional patient populations.