The News

Ablynx reports detailed positive phase Ib results for its anti-thrombotic Nanobody® ALX-0081

30/03/2009

GHENT, Belgium, 30 March 2009 - Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today the detailed results from the Phase Ib study of its anti-thrombotic ALX-0081. The primary endpoint, demonstrating the complete inhibition of the target protein as measured by a specific biomarker, was reached in December 2008. These positive detailed data support the progression of ALX-0081 into Phase II testing, expected to commence in Q3 2009.
 
During the period May to December 2008, the study recruited a total of 25 patients with stable angina undergoing an elective percutaneous coronary intervention (PCI) procedure. Total daily doses of ALX-0081 ranging from 2 to 18 mg were added to a standard anti-thrombotic regimen including aspirin, heparin and Plavix®. The double blind study randomized patients in a 3:1 ratio to either active study drug (ALX-0081) or placebo, resulting in a total of 19 patients receiving ALX-0081 intravenous infusions and six patients receiving placebo. The biological effect of ALX-0081 was determined via a biomarker, indicating the complete inhibition of von Willebrand Factor (vWF) and its mediated effect on platelet aggregation and clotting in coronary arteries.
 
The study included a single dose and a multiple dose escalation. Single doses were escalated until the required biological effect (complete biomarker inhibition for at least six hours in all ALX-0081 treated patients) was confirmed. The subsequent multiple dosing was aimed to ensure complete inhibition of the biomarker for at least 24 hours. All patients who received ALX-0081 showed complete inhibition of the biomarker with a duration of 4 to 18 hours in the single dose group and for at least 24 hours in the multiple dose group. In all patients, the pharmacological markers returned to normal 12-36 hours after dosing.
 
 
For more information, please contact:
 
College Hill Life Sciences - for UK/International media enquiries:
Sue Charles, Justine Lamond, Dr John McIntyre
t:   +44 (0)20 7866 7857
e:  ablynx@collegehill.com
 
Ablynx:
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
e:  edwin.moses@ablynx.com
 
Eva-Lotta Allan
Chief Business Officer
t:   +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
e:  eva-lotta.allan@ablynx.com
 

Complete version of the press release in English