GHENT, Belgium, 2 July, 2007 -- Ablynx today announced positive interim results from the ongoing Phase I study of its lead development programme, ALX-0081, an anti-thrombotic treatment. ALX-0081 is a novel ´first-in-class´ therapeutic Nanobody® targeting von Willebrand Factor (vWF), which can reduce the risk of thrombosis in patients with acute coronary syndrome.
The Phase I study in healthy volunteers is designed to assess safety, tolerability and pharmacokinetics of ALX-0081. It will also analyse pharmacodynamic effects of ALX-0081 to confirm its high potency. It is a double-blind, placebo-controlled trial in healthy male volunteers at a single center in Europe.
The study was initiated during the first quarter of 2007. The interim analysis indicates:
- the desired pharmacodynamic effect was observed as anticipated indicating the high potency of ALX-0081
- ALX-0081 was well tolerated and showed no serious adverse effects or dose limiting toxicity
The final results are anticipated to be available by the end of September 2007.
Dr Edwin Moses, CEO and Chairman said: "We are very encouraged by the positive results of our first Nanobody® in clinical development which is believed to be the first ever single domain antibody human trial. This is a significant milestone for Ablynx and demonstrates the success of Ablynx´s powerful discovery platform."
Through its novel, highly selective mode of action, ALX-0081 is intended to prevent arterial thrombosis, without interfering with the desired haemostatis (wound healing) in the patient which results in less bleeding complications. Pre-clinical in vivo studies confirmed Ablynx´s belief that ALX-0081 has unique potential to set a new standard in anti-thrombotic therapy based on its immediate onset of action, its high potency and significantly improved safety compared to the currently marketed therapies in the form of significantly reduced bleeding complications. Ablynx has demonstrated a large therapeutic window for ALX-0081 based on the high efficacy and low bleeding demonstrated in primate studies, indicating a highly attractive drug profile.
Dr. Edwin Moses
Chairman and CEO
t : +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
Chief Business Officer
t : +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
Visit our website: http://www.ablynx.com
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