GHENT, Belgium – Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today that its anti-thrombotic ALX-0081, has reached the primary endpoint of the current Phase Ib study, demonstrating the desired pharmacological effect.
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 (PCI) 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 “first-in-class” therapeutic Nanobody® targeting von Willebrand Factor. It is being developed to reduce the risk of thrombosis in patients with acute coronary syndrome (ACS). These positive Phase Ib results will now support the progress into Phase II clinical development in 2009.
Edwin Moses, CEO and Chairman 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.”
Earlier this week Ablynx announced the initiation of Phase I trials for two additional Nanobodies®. Firstly, ALX-0681, which also targets von Willebrand Factor and is administered subcutaneously, entered a healthy volunteer study. It is anticipated that subcutaneous administration of ALX-0681 will provide access to additional patient populations suffering from unwanted blood-clot formation, such as acute coronary syndrome (ACS), that are not currently addressed by the intravenous administration of Ablynx’s anti-thrombotic ALX-0081. In addition, ALX-0681 is also being developed for the treatment of patients with thrombotic thrombocytopenic purpura (TTP).
The second healthy volunteer study initiated this week involved a Nanobody® targeting tumour necrosis factor alpha, partnered with Wyeth Pharmaceuticals.
“We are delighted to see three Nanobodies® in the clinic and look forward to further progress in clinical development,”
added Dr Moses.