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news.Ablynx has announced the positive data from a proof-of-concept (POC) Phase II study evaluating the efficacy of anti-vWF Nanobody, ALX-0081 in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
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Ablynx’s anti-vWF Nanobody is a bivalent construct, consisting of two Nanobodies targeting the vWF, which has an increased potency compared with the monovalent format.
The open-label multi-national, multi-institutional Phase II study enrolled a total of 380 high risk ACS patients undergoing PCI, who were randomized to receive either ALX-0081 or the GPIIb/IIIa inhibitor ReoPro.
In addition, all patients received the standard anti-thrombotic regimen of aspirin, heparin and Plavix.
The primary endpoint of the study was a composite of all bleeding events according to the TIMI (thrombolysis in myocardial infarction) classification and it was assessed for all patients within 30 days of study drug administration.
The data showed that 36 (19.9%) patients reported bleeding events in the ALX-0081 treatment group and 28 (15.3%) patients reported bleeding events in the ReoPro treatment group.
Only three ALX-0081 treated patients (1.7%) and two ReoPro treated patients (1.1%) showed a major bleeding event during the 30 day period following the PCI procedure.