Ablynx started a phase II study in TTP - in addition announces €3 million milestone payments
GHENT, Belgium - Ablynx [Euronext Brussels: ABLX] announced that it has opened recruitment in its first clinical trial centre for an open-label, randomised Phase II study for patients with acquired thrombotic thrombocytopenic purpura (TTP). This Phase II study will be conducted in Europe and North America and it is planned to enroll over 100 patients. Ablynx's anti-von Willebrand factor (vWF) Nanobody® was granted orphan drug designation for the treatment of TTP in May 2009, by both the U.S. Food and Drug Administration and the European Commission.
During the Phase II study, the Nanobody will be administered to TTP patients as an adjunct to standard plasma exchange therapy. The primary endpoint of the study will be the time to response, defined by the normalisation of platelet count and the blood marker lactate dehydrogenase (LDH). The study goal is to see a significant reduction in the time to response for the anti-vWF treated population compared with placebo treatment. It is anticipated that this could translate into a shorter duration of life-threatening episode, a reduction of the number of plasma exchanges required and the amount of plasma product administered.
Dr Edwin Moses, CEO and Chairman of Ablynx commented:
"There is currently no drug treatment approved specifically for TTP. Patients are often hospitalised for up to two weeks and have to receive frequent plasma exchanges which are costly and can lead to serious side effects such as allergic reactions or infections. Despite the plasma exchange treatment, the condition is very serious with up to 20% mortality. We believe that our anti-vWF Nanobody may reduce the number of days a TTP patient is hospitalised for plasma exchange thereby reducing the overall number of plasma transfusions and increasing the quality of life for these patients." He added: "This is the third Nanobody programme entering Phase II clinical trials."
In addition, Ablynx announced today that it will receive further milestone payments totalling €3 million from Boehringer Ingelheim, triggered as part of its strategic alliance for the development and commercialisation of Nanobodies®. Ablynx has now earned a total of €12 million in milestone payments as part of this agreement.
Ablynx and Boehringer Ingelheim entered into an agreement in September 2007 to collaborate on the discovery, development and commercialisation of up to 10 different Nanobody therapeutics across a range of areas including for example immunology, oncology and respiratory diseases. The agreement would allow potential milestone payments of up to €125 million for each Nanobody developed as well as undisclosed royalties to Ablynx. Boehringer Ingelheim is exclusively responsible for the development, manufacture and commercialisation of any products resulting from the collaboration. Ablynx retains certain co-promotion rights in Europe.
For more information, please contact 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
About Ablynx [Euronext Brussels: ABLX] - www.ablynx.com
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 250 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007 and raised €50 million through an SPO in March 2010.
Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer's disease. Ablynx now has over 25 programmes in its therapeutic pipeline including four Nanobodies in clinical development. So far, Nanobodies have been successfully generated against more than 220 different protein targets including several complex targets such as chemokines, GPCRs, ion channels and viruses, which are typically very difficult to address with conventional monoclonal antibodies.