Biotech Values

[DewDiligence]

Ablynx Initiates Phase-2 Trial for ALX-0081 in PCI

[Please see the annotations in the prologue of #msg-40720487. According to this PR, the additional formulation work on ALX-0061 that was required before starting phase-2 has been completed and details will be disclosed “in a few months.”]

http://hugin.info/137912/R/1338761/319541.pdf

›GHENT, Belgium, 1 September 2009 - Ablynx [Euronext Brussels: ABLX] today 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. [As previously reported:] 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.”

There are currently three Nanobodies in clinical development of which ALX-0081 is the most advanced. Ablynx’s ALX-0681, also an anti-thrombotic but with a subcutaneous route of administration, is currently in Phase I in healthy volunteers. The third Nanobody is in development with Wyeth Pharmaceuticals targeting tumor necrosis factor alpha (TNF-alpha), which entered Phase I in December 2008. Ablynx believes Wyeth may initiate a Phase II proof-of-concept study in patients with rheumatoid arthritis with its licensed anti-TNF-alpha Nanobody, which will trigger a milestone for the Company.

About ALX-0081 and ALX-0681

ALX-0081 and ALX-0681 are novel “first-in-class” therapeutic Nanobodies targeting von Willebrand factor ("vWF"), a protein found in the blood that acts at a very early stage in the coagulation cascade, namely platelet adhesion, in contrast to currently available anti-platelet drugs which act only in the late stage of platelet aggregation. ALX-0081 is administered intravenously while ALX-0681 is administered subcutaneously. ALX-0081 is a bivalent Nanobody with a molecular weight of 28,000 daltons, designed fragments, for a range of serious and life-threatening human diseases. The Company currently has over 220 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.

Ablynx is developing a portfolio of Nanobody-based therapeutic programmes in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Nanobodies have been generated against more than 150 different disease targets. Importantly the Nanobodies which naturally exist in llamas have a very high homology with humans. Efficacy data has been obtained in over 26 in vivo models for Nanobodies against a range of different targets.

Ablynx has an extensive patent position in the field of Nanobodies for healthcare applications. It has exclusive and worldwide rights to more than 50 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies.

Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Wyeth Pharmaceuticals. Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations as well as through its own internal discovery programmes.

The Company’s lead programme, ALX-0081, an intravenously administered novel anti-thrombotic has entered Phase II in patients undergoing percutaneous coronary intervention (PCI). ALX-0681, also an anti-thrombotic but with a subcutaneous route of administration has concluded a Phase I study in healthy volunteers. Ablynx has progressed ALX-0141, an anti-RANKL Nanobody for bone disorders into preclinical development and aims to initiate a Phase I study before the end of 2009. ALX-0061, an anti IL6R Nanobody is in preclinical development for the treatment of autoimmune and inflammatory diseases. In addition, Ablynx’s partner Wyeth Pharmaceuticals is currently in Phase I study with an anti- TNF-alpha Nanobody. Nanobody is a registered trademark of Ablynx NV.‹