Ablynx has initiated a double-blind, randomised, placebo-controlled multiple dose Phase Ib study for its novel anti-thrombotic that selectively targets von Willebrand (vWF) factor
The study is being conducted in patients with stable angina undergoing percutaneous coronary intervention (PCI).
The company also provides its first business update in compliance with the EU transparency directive summarising material events and Ablynx's financial position for the first quarter of 2008.
"Based on the success of the Phase Ia study announced in December 2007, we are delighted to have advanced ALX-0081 directly into patients as opposed to needing to carry out a multiple-dose Phase I study in healthy volunteers", said Edwin Moses, chief executive officer and chairman.
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.
It is intended to recruit up to 64 patients with stable angina for this study.
Dosing regimes relevant for the treatment of acute coronary syndrome (ACS) 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.
