ABLYNX Reports Positive Phase Ib Results for its Anti-Thrombotic NANOBODY® ALX-0081 - Gilde Healthcare

ABLYNX Reports Positive Phase Ib Results for its Anti-Thrombotic NANOBODY® ALX-0081

December 12, 2008

GHENT, Belgium – Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today that its anti-thrombotic ALX-0081, has reached the primary endpoint of the current Phase Ib study, demonstrating the desired pharmacological effect.

The objectives of the double-blind, randomized, placebo-controlled multiple dose Phase Ib study were to determine safety and tolerance when adding ALX-0081 via intravenous administration to a standard anti-thrombotic regimen in patients undergoing percutaneous coronary intervention (PCI) and to determine biological efficacy using a biomarker. The study involved a total of 25 patients and ALX-0081 administration was shown to be safe and well tolerated.

ALX-0081 is a novel “first-in-class” therapeutic Nanobody® targeting von Willebrand Factor. It is being developed to reduce the risk of thrombosis in patients with acute coronary syndrome (ACS). These positive Phase Ib results will now support the progress into Phase II clinical development in 2009.

Edwin Moses, CEO and Chairman said:

“We are extremely pleased with these positive results in patients and the first demonstration of the clinical potential of ALX-0081. Impressively, ALX-0081 has been progressed from discovery to completion of this Phase Ib study in only four years, illustrating the speed at which our discovery platform can generate a therapeutic product. Based on these positive data, we look forward to initiating our discussions with the regulatory authorities and embarking on a Phase II study in 2009.”

Earlier this week Ablynx announced the initiation of Phase I trials for two additional Nanobodies®. Firstly, ALX-0681, which also targets von Willebrand Factor and is administered subcutaneously, entered a healthy volunteer study. It is anticipated that subcutaneous administration of ALX-0681 will provide access to additional patient populations suffering from unwanted blood-clot formation, such as acute coronary syndrome (ACS), that are not currently addressed by the intravenous administration of Ablynx’s anti-thrombotic ALX-0081. In addition, ALX-0681 is also being developed for the treatment of patients with thrombotic thrombocytopenic purpura (TTP).

The second healthy volunteer study initiated this week involved a Nanobody® targeting tumour necrosis factor alpha, partnered with Wyeth Pharmaceuticals.

“We are delighted to see three Nanobodies® in the clinic and look forward to further progress in clinical development,”

added Dr Moses.

Gilde Healthcare company NIZO acquires lactic acid facility and strengthens partnership with DSM-firmenich

NIZO food research B.V. (“NIZO”) is proud to announce the signature of a long-term contract manufacturing partnership with dsm-firmenich. This strategic alliance encompasses the acquisition of the neighboring lactic acid facility from Vika Nutrition B.V.,...
February 29, 2024

Gilde Healthcare co-leads oversubscribed €54 Million Series B round of Argá Medtech

Argá Medtech, a company developing a next-generation cardiac ablation system for treating cardiac arrhythmias, including atrial fibrillation (AF), announced it closed a €54M oversubscribed Series B raise co-led by Gilde Healthcare with existing investors, Advent...
February 28, 2024

Gilde Healthcare leads $125 Million Equity Financing of Mainstay Medical

Funding to accelerate commercial growth and expand clinical and health economic evidence for ReActiv8® Restorative NeuromodulationTM System Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125...
February 27, 2024