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Ablynx reports phase II dara for ALX-0081 in high risk ACS patients undergoing a PCI procedure
16-Nov-2011
- Belgium
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Ablynx announced head-line data from a proof-of-concept (POC) Phase II study with the anti-vWF Nanobody, ALX-0081, in high risk patients with Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
In this multi-national, multi-institutional, open-label Phase II study, Ablynx enrolled a total of 380 high risk ACS patients undergoing PCI. These patients were randomized to receive either ALX-0081 or the GPIIb/IIIa inhibitor ReoProÒ. 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 bleeding events were judged by a blinded central endpoint review committee comprised of haematology, cardiology and clinical pharmacology experts. The primary endpoint was designed to show a 40% reduction in bleeding events with ALX-0081 compared with ReoPro®. This goal was not achieved as there was no statistically significant difference between the total number of bleeding events for the two compounds. Both ALX-0081 and ReoPro® showed comparable bleeding profiles as outlined below:
- 36 (19.9%) patients reported bleeding events (insignificant, minor and major bleeds) in the ALX-0081 treatment group (n=181) and 28 (15.3%) patients reported bleeding events (insignificant, minor and major bleeds) in the ReoPro® treatment group (n=183).
- 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.
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