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 it has initiated a double-blind, randomized, placebo-controlled Phase I study in healthy volunteers with ALX-0681. The subjects will receive a subcutaneous injection of the novel anti-thrombotic Nanobody® that selectively targets von Willebrand (vWF) factor.
The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated subcutaneous administrations of ALX-0681. Ablynx will recruit up to 36 healthy volunteers for this 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 ALX-0081. In addition, ALX-0681 is also being developed for the treatment of patients with thrombotic thrombocytopenic purpura (TTP).
“Ablynx is committed to developing its own internal pipeline of Nanobody®-based drugs and, with the positive progress to date of our lead product, ALX-0081, which also selectively targets von Willebrand factor, we are delighted to have now advanced a second product from our platform, ALX-0681, into a healthy volunteer Phase I study,”
commented Dr Edwin Moses, Chairman and Chief Executive Officer.
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About ALX-0681 and ALX-0081
ALX-0681 and ALX-0081 are novel “first-in-class” therapeutic Nanobodies® targeting von Willebrand factor (“vWF”), a protein found in the blood that acts at a very early stage in the coagulation cascade, namely platelet adhesion, in contrast to currently available anti-platelet drugs which act only in the late stage of platelet aggregation. ALX-0081 is administered intravenously while ALX-0681 is administered subcutaneously. ALX-0681, a new potential anti-thrombotic agent, is a bivalent Nanobody® with a molecular weight of 28,000 daltons, designed to selectively prevent unwanted thrombus formation in vessels under high shear conditions without interfering with desirable haemostasis and, as such, to minimize bleeding complications.