ALX-0081: Development discontinued

Ablynx said it will not pursue development of ALX-0081 to treat ACS at this time after data from an open-label, international Phase II trial in 380 high-risk patients with ACS undergoing PCI showed that ALX-0081 missed that the primary endpoint of significantly reducing a composite rate of all bleeding events according to TIMI criteria within 30 days of treatment compared to ReoPro abciximab (19.9% vs. 15.3%). Ablynx said the trial was designed to show a 40% reduction in bleeding events with ALX-0081 vs. ReoPro. Additionally, 3 and 2 patients receiving ALX-0081 and ReoPro, respectively, experienced a major bleeding event during the 30-day period following PCI. All patients received a standard anti-thrombotic regimen of aspirin, heparin and Plavix clopidogrel.

Ablynx said it will now focus on developing ALX-0081 and its subcutaneous formulation, ALX-0681, to treat thrombotic thrombocytopenic purpura ( TTP). The Phase II TITAN trial is evaluating ALX-0081 followed by ALX-0681 in TTP. Final data are expected by the end of 2013. ALX-0081 has Orphan Drug designation in the U.S. and EU for TTP. ...