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news.Ablynx, a developer of Nanobodies, 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 factor.
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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, 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.
Edwin Moses, chairman and CEO of Ablynx, said: “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.”