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news.Ablynx, a biopharmaceutical company, has announced that its anti-thrombotic ALX-0081, has reached the primary endpoint of the current Phase Ib study, demonstrating the desired pharmacological effect.
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The objectives of the double-blind, randomized, placebo-controlled multiple dose Phase Ib 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. The study involved a total of 25 patients and ALX-0081 administration was shown to be safe and well tolerated.
ALX-0081 is a novel therapeutic Nanobody targeting von Willebrand Factor. It is being developed to reduce the risk of thrombosis in patients with acute coronary syndrome. These positive Phase Ib results will now support the progress into Phase II clinical development in 2009.
Edwin Moses, CEO and chairman of Ablynx, said: “We are extremely pleased with these positive results in patients and the first demonstration of the clinical potential of ALX-0081. 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.”