ALX-0081 misses in ACS, continuing in TTP
Ablynx N.V. (Euronext:ABLX) said it will not pursue development of ALX-0081 to treat acute coronary syndrome after the product missed the primary endpoint in a Phase II trial in 380 high-risk patients with ACS undergoing percutaneous coronary intervention (PCI). The product did not significantly reduce a composite rate of all bleeding events within 30 days of treatment compared to ReoPro abciximab (19.9% vs. 15.3%). ALX-0081 is an IV formulation of a Nanobody targeting von Willebrand factor (vWF).
Ablynx said it will now focus on developing ALX-0081 and its subcutaneous formulation, ALX-0681, to treat thrombotic thrombocytopenic purpura (TTP). Final data from the Phase II TITAN trial, which is evaluating ALX-0081 followed by ALX-0681 for TTP, are expected by year end 2013. Ablynx was off EUR 0.02 to EUR 2.69 on Thursday. ...