GHENT, BELGIUM--(Marketwire - December 22, 2009) - Ablynx (Euronext Brussels: ABLX) announced today 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.”
For more information, please contact: College Hill Life Sciences - for International media enquiries: Sue Charles, Justine Lamond t: +44 (0)20 7866 7857 f: +44 (0)20 7866 7900 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: http://hugin.info/137912/R/1366705/334088.pdf
