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Ablynx reports detailed positive Phase Ib results for its anti-thrombotic nanobody ALX-0081

01 Apr 2009 - Ablynx announced the detailed results from the Phase Ib study of its anti-thrombotic nanobody 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.