Ablynx Demonstrates Proof-of-Concept by Biomarker For Its Anti-Thrombotic ALX-0081

23-Dec-2009 - Belgium

Ablynx announced detailed results from the open label extension of the Phase Ib study of its anti-thrombotic, ALX-0081, in patients with stable angina undergoing percutaneous coronary intervention (PCI). The results support those of the original Phase I study with ALX-0081 and collectively provide proof-of-concept that ALX-0081 is safe and well tolerated and a potent inhibitor of platelet aggregation.

The study was designed to investigate the effect of ALX-0081, which inhibits von Willebrand Factor (vWF), on vWF-mediated clotting, measured using platelet aggregation biomarkers. Additional objectives were to gather additional data regarding safety and administration. The study recruited a total of 22 patients with stable angina undergoing elective PCI. All patients received standard anti-thrombotic therapy, including aspirin, heparin and Plavix® in addition to ALX-0081 (20 patients; total dose 18mg) or placebo (2 patients).

All 22 patients received four bolus injections (i.v.) of ALX-0081 or placebo every six hours over 24 hours. vWF-mediated platelet aggregation was measured via the biomarker RICO (ristocetin cofactor). All 20 patients who received ALX-0081 experienced complete RICO inhibition, that was statistically significant compared with placebo, (p<0.0001). ALX-0081 was safe and well tolerated and did not result in clinically relevant bleeding events. No evidence of anti-drug antibodies was detected up to 30 days after the last injection.

Professor Jozef Bartunek, (Aalst, Belgium) primary investigator of the Phase Ib study commented: “With the highly statistically significant inhibition of vWF, we have achieved proof-of-concept with the biomarker indicating ALX-0081 is a potent inhibitor of vWF-mediated clotting in patients with stable angina undergoing PCI.”

Edwin Moses, CEO and Chairman at Ablynx, commented: “We are delighted to see further evidence of efficacy and safety for ALX-0081 in patients with cardiovascular disease. This is a novel target and ALX-0081 could become an important next generation thrombosis treatment. Ablynx recently initiated a Phase II study with ALX-0081 and we look forward to obtaining data from this study by the end of 2010.”

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Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous