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news.Ablynx has reported positive results from a double-blind, placebo-controlled Phase I study in 40 healthy male volunteers that demonstrated the efficacy of its lead development program, ALX-0081, an anti-thrombotic therapeutic.
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In the study, treatment with the nanobody did not result in detectable immunogenicity. The study suggests that ALX-0081 adopts at least the plasma half-life of the target, von Willebrand Factor. The expected anti-thrombotic activity was shown with a biomarker in all volunteers receiving at least 2mg of ALX-0081, indicating the high potency of the drug.
ALX-0081’s pharmacological activity, based on a single injection, started at the lowest dose of 2mg and reached a maximum duration of 12 hours at a dose of 12mg. ALX-0081 was safe and well tolerated at all doses tested, with no dose limiting toxicities or serious adverse events.
ALX-0081, generated through Ablynx’s in-house discovery platform, is a novel first-in-class therapeutic nanobody targeting von Willebrand Factor (anti-vWF). It is being developed to reduce the risk of thrombosis in patients with acute coronary syndrome (ACS) and thrombotic thrombocytopenic purpura (TTP). Following these positive Phase I results, Ablynx will now progress ALX-0081 to a multi-dose study in 2008.
Edwin Moses, CEO and chairman of Ablynx, said: “Based on these positive data, we are looking forward to initiating our discussions with the regulatory authorities this year and embarking on our next clinical study in 2008 in order to progress programs in acute coronary syndrome and TTP.”