Ablynx meets endpoint in ACS study

Belgian drug developer Ablynx says that its anti-thrombotic ALX-0081 has reached the primary endpoint of the current Phase Ib study. The  objectives of the double-blind, randomized, placebo-controlled,  multiple-dose study were to determine safety and tolerance when adding  ALX-0081 via intravenous administration to a standard anti-thrombotic  regimen in patients undergoing percutaneous coronary intervention and to  determine biological efficacy using a biomarker.

ALX-0081 is a novel first -in-class therapeutic Nanobody targeting the  von Willebrand Factor. It is being developed to reduce the risk of  thrombosis in patients with acute coronary syndrome. The firm says the  positive results will support the drug's progress into Phase II clinical  development in 2009.

Chief executive Edwin Moses said: "we are extremely pleased with these  positive results in patients and the first demonstration of the clinical  potential of ALX-0081. Impressively, ALX-0081 has been progressed from  discovery to completion of this Phase Ib study in only four years,  illustrating the speed at which our discovery platform can generate a  therapeutic product. Based on these positive data, we look forward to  initiating our discussions with the regulatory authorities and embarking  on a Phase II study in 2009."