Ablynx Initiates Phase II Clinical Trial For ALX-0081
Ablynx announced the initiation of a Phase II study for its anti-thrombotic Nanobody® ALX-0081, a first-in-class Nanobody® targeting von Willebrand Factor (vWF). The open-label, randomized Phase II study is designed to evaluate the safety and efficacy of multiple doses of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in patients undergoing percutaneous coronary intervention (PCI). Patients with unstable angina or patients with stable angina with at least two factors indicating high risk will be included in this study. ALX-0081 or ReoPro® will be added to a standard anti-thrombotic regimen including aspirin, heparin and Plavix®. This multi-institutional, pan-European Phase II study is planned to enroll close to 370 patients
Ablynx recently concluded a successful ALX-0081 Phase Ib study in patients with stable angina undergoing a planned PCI procedure. The drug’s biological effect was determined using a biomarker, indicating the complete inhibition of vWF and its mediated effect on platelet aggregation and clotting in coronary arteries. ALX-0081 showed an excellent efficacy and safety profile in this patient study. In order to gain additional information on optimal dosing and scheduling, Ablynx has extended this Phase Ib study to look in more detail at biological markers, optimization of concurrent treatment with the standard anti-thrombotic regimen, tolerance and administration. Data from this Phase Ib study extension will be reported in a few months.
“Initiation of Phase II clinical development of ALX-0081 is a major milestone for Ablynx,” commented Edwin Moses, CEO and Chairman. “This study builds on our recent rapid progress and success, generating encouraging safety and efficacy data in patients. ALX-0081 has the potential to become a safe, first-in-class anti-platelet agent. We are delighted that the first patient in this important study was treated in Aalst, Belgium.”
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