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Ablynx reports positive Phase I results for its
anti-thrombotic NanobodyR, ALX-0081
GHENT, Belgium, 17 December 2007 - Ablynx [Euronext
Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®,
a novel class of antibody-derived therapeutic proteins, today reported the
final, positive results from a Phase I study of its lead development
programme, ALX-0081. The results of the double-blind, placebo controlled
study in 40 healthy male volunteers show that ALX-0081, an anti-thrombotic
therapeutic, was safe and well tolerated at all doses tested, with no dose
limiting toxicities or serious adverse events.
ALX-0081, generated through Ablynx’s in-house discovery platform, is a novel
“first-in-class” therapeutic Nanobody® targeting von Willebrand Factor
(anti-vWF). It is being developed to reduce the risk of thrombosis in
patients with acute coronary syndrome (ACS) and thrombotic thrombocytopenic
purpura (TTP). Following these positive Phase I results, Ablynx will now
progress ALX-0081 to a multi-dose study in 2008.
In the study, treatment with the Nanobody® did not result in detectable
immunogenicity. The study suggests that ALX-0081 adopts at least the plasma
half-life of the target, von Willebrand Factor. The expected anti-thrombotic
activity was shown with a biomarker in all volunteers receiving at least 2mg
of ALX-0081, indicating the high potency of the drug. ALX-0081’s
pharmacological activity, based on a single injection, started at the lowest
dose of 2 mg and reached a maximum duration of 12 hours at a dose of 12 mg.
Edwin Moses, CEO and Chairman said: “We are extremely pleased with these
positive safety results and demonstration of the high potential potency of
ALX-0081, our first Nanobody® in clinical development. In addition, ALX-0081
has been progressed from discovery to completion of Phase I in just over
three years, demonstrating the speed at which our discovery platform can
generate a novel therapeutic. Based on these positive data, we are looking
forward to initiating our discussions with the regulatory authorities this
year and embarking on our next clinical study in 2008 in order to progress
programmes in acute coronary syndrome and TTP.”
-ends-
About ALX-0081
ALX-0081 is a Nanobody® targeted against 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 work only in the late stage of platelet
aggregation. The addition of ALX-0081 to the range of tools currently
employed in an anti-thrombotic regimen may, therefore, have the potential to
improve the overall efficacy of anti-platelet aggregation therapy and lead
to an increased use of anti-thrombotic treatment in clinical indications
like ACS where there is a high need for immediate and safe therapy.
Through its novel, highly selective mode of action, ALX-0081 is intended to
prevent arterial thrombosis, without interfering with the desired
haemostatis (wound healing) in the patient which results in less bleeding
complications. Pre-clinical in vivo studies confirmed Ablynx’s belief that
ALX-0081 has unique potential to set a new standard in anti-thrombotic
therapy based on its immediate onset of action, its high potency and
significantly improved safety compared to the currently marketed therapies
in the form of significantly reduced bleeding complications.
About ACS and TTP
Acute coronary syndrome (ACS) is expected to afflict approximately 2.8
million people in the Unites States, Japan and certain European countries in
2007 and is the leading cause of mortality in the area of cardiovascular
disease. Experts believe that the prevalence and incidence of acute infarcts
due to arteriosclerosis will further increase, due to the ageing population.
Peripheral arterial occlusive disease (PAOD) will affect an estimated 21.7
million individuals in the US, Japan and certain European countries in 2007
and is associated with significant morbidity and mortality.
Another disease related to the formation of white clots is thrombotic
thrombocytopenic purpura (TTP). The underlying abnormality in TTP is the
formation of small platelet clots, which leads to occlusions of small
vessels throughout the body particularly within blood vessels supplying the
brain and the kidneys. It has been shown that these small platelet clots are
caused by the presence of large clumps of von Willebrand Factor (vWF).
Approximately four cases of TTP per million inhabitants are diagnosed per
year in Europe and the United States. There is currently no approved drug
therapy for TPP and plasma exchange is the only available treatment for
these patients today. Plasma exchange involves the removal of the patient’s
plasma and its replacement by donor plasma. TTP remains a condition with
extremely high morbidity and mortality, even with timely plasma exchange,
and so there is still a significant unmet medical need for this disease.
Besides ACS and TTP, another relevant indication for ALX-0081 is ischemic
stroke. After heart disease and cancer, stroke is the third most frequent
cause of death in the Western world. It is estimated that over two million
people suffer a stroke annually. Mortality is high with 20% of patients
dying, whilst the majority of the remainder is left permanently disabled.
About Ablynx – http://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 140 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 100 different disease targets. Efficacy data has been obtained in
16 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
fifty 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,
Wyeth Pharmaceuticals, Novartis, and P&G Pharma. Ablynx is building a
diverse and broad portfolio of therapeutic Nanobodies® through these
collaborations as well as through its own internal discovery programmes.
Ablynx announced final Phase I data from its first programme, an anti-thrombotic
(ALX-0081) in December 2007 and another programme, which is partnered, is in
advanced preclinical development.
Nanobody® is a registered trademark of Ablynx NV.
For more information, please contact:
UK/International media enquiries
College Hill Life Sciences
Sue Charles, Justine Lamond, Holly Griffiths
t: +44 (0)20 7457 2020
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
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