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Clinical Studies

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Date: 2009-12-22
Phase: I-II
Anouncement: Result
Biotech: Ablynx (Belgium)
Product: ALX-0081 (Nanobody® targeting von Willebrand factor)
Disease: patients with stable angina undergoing percutaneous coronary intervention (PCI)
Other: Ablynx has announced detailed results from the open label extension of the Phase Ib study of its anti-thrombotic, ALX-0081, in patients with stable angina undergoing percutaneous coronary intervention (PCI).
The results support those of the original Phase I study with ALX-0081 and collectively provide proof-of-concept that ALX-0081 is safe and well tolerated and a potent inhibitor of platelet aggregation (See clinical_studies)

The study was designed to investigate the effect of ALX-0081, which inhibits von Willebrand Factor (vWF), on vWF-mediated clotting, measured using platelet aggregation biomarkers. The study recruited a total of 22 patients with stable angina undergoing elective PCI. All patients received standard anti-thrombotic therapy, including aspirin, heparin and Plavix® in addition to ALX-0081 (20 patients; total dose 18mg) or placebo (2 patients).

All 22 patients received four bolus injections (i.v.) of ALX-0081 or placebo every six hours over 24 hours. vWF-mediated platelet aggregation was measured via the biomarker RICO (ristocetin cofactor). All 20 patients who received ALX-0081 experienced complete RICO inhibition, that was statistically significant compared with placebo, (p<0.0001).
ALX-0081 was safe and well tolerated and did not result in clinically relevant bleeding events. No evidence of anti-drug antibodies was detected up to 30 days after the last injection.

Ablynx recently initiated a Phase II study with ALX-0081 (See clinical_studies). Data from this study are expected by the end of 2010.