Date: 2011-11-10
Type of information: Results
phase: 2
Announcement: Results
Company: Ablynx (Belgium)
Product: ALX-0081
Action
mechanism: ALX-0081 is an intravenous form of a humanised bivalent Nanobody that inhibits the interaction of vWF (von Willebrand Factor) with the GP1b receptor on platelets. Due to its small size and flexible format it is able to interact with multiple binding domains on the vWF protein, resulting in high potency.
Disease: Acute coronary syndrome (ACS)
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: 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 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 bleeding events were judged by a blinded central endpoint review committee comprised of haematology, cardiology and clinical pharmacology experts.
Latest
news: Ablynx has 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).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. Since there is no statistical difference between the safety profile of ALX-0081 and ReoPro®, and with the increasing, and intense commercial competition in this area, Ablynx has decided not to pursue the ACS indication further at this time. The company will focus its attention and activities with anti-vWF Nanobodies on the orphan disease indication TTP where Ablynx is currently conducting a Phase II study in patients with acquired TTP.
