ABLYNX TO PRESENT A POST-HOC ANALYSIS OF THE PHASE II TITAN STUDY WITH CAPLACIZUMAB IN ACQUIRED TTP PATIENTS AT THE 21st CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION
(Thomson Reuters ONE) -
Post-hoc analysis of the TITAN data showed that treatment with caplacizumab
significantly reduced a composite endpoint of major thromboembolic events and
mortality
GHENT, Belgium, 26 May 2016 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today
announced that a post-hoc analysis of the worldwide Phase II TITAN study of its
wholly-owned Nanobody®, caplacizumab, in patients with acquired thrombotic
thrombocytopenic purpura (aTTP), will be presented at the 21(st) Congress of the
European Hematology Association (EHA), being held from 9-12 June 2016 in
Copenhagen, Denmark.
It has been previously reported that the efficacy and safety of caplacizumab in
conjunction with the standard of care (plasma exchange) were evaluated in a
Phase II study in 75 patients with aTTP. Caplacizumab was well-tolerated and the
primary endpoint of a reduction in time to platelet normalisation was achieved
with statistical significance (p= 0.005). In addition, during treatment,
caplacizumab reduced aTTP recurrences by 71% compared to placebo when
administered as an adjunct to standard of care[1].
Despite the current standard of care, mortality from an episode of acquired TTP
is still reported to be up to 20% and patients remain at risk of life-
threatening thrombotic complications. A post-hoc analysis of the Phase II data
was performed to assess the impact of caplacizumab on a composite endpoint of
major thromboembolic events and TTP-related mortality. The results demonstrate
that a significantly lower proportion of subjects treated with caplacizumab
experienced one or more major thromboembolic events, or died, as compared to
placebo (11.4% versus 43.2%, nominal p-value of 0.006). These clinically
meaningful results suggest that treatment with caplacizumab has the potential to
reduce the major morbidity and mortality associated with acquired TTP.
The results from this post-hoc analysis will be presented during a poster
presentation on 10 June 2016, from 17:15 to 18:45 CET (poster Hall H). The
abstract (LB418): "Impact of caplacizumab treatment on mortality and major
thromboembolic events in acquired TTP: Phase II TITAN study results", is
available on the EHA website at www.ehaweb.org.
About caplacizumab and the TITAN study results
Caplacizumab is a highly potent and selective bivalent anti-von Willebrand
Factor (vWF) Nanobody that received Orphan Drug Designation in the USA and EU in
2009. Caplacizumab inhibits the interaction between ultra-large vWF and
platelets by targeting the A1 domain of vWF. It thereby prevents platelet
aggregation and the formation of micro-clots during the acute, critical phase of
acquired TTP.
Caplacizumab's clinical effect was demonstrated in the Phase II TITAN study in
75 patients with aTTP:
* As indicated by a nearly 40% reduction in median time to platelet count
normalisation (p = 0.005). Treatment with caplacizumab reduced the use of
daily plasma exchange (PEX) and prevented further formation of micro clots
and small blood vessel occlusion.
* As shown by the low number of recurrences requiring re-initiation of daily
plasma exchange during treatment with caplacizumab (N=3) vs. placebo (N=11).
These results will serve as the basis for filing for conditional approval of
caplacizumab in Europe in H1 2017. The confirmatory Phase III HERCULES study is
currently ongoing to support the BLA filing in the USA. Results from this Phase
III study are expected by the end of 2017. Caplacizumab could be the first
therapeutic specifically approved for the treatment of acquired TTP.
About aTTP
aTTP is an acute life-threatening, ultra-rare, blood clotting disorder,
affecting up to 11 per million people worldwide. It has a sudden onset caused by
impaired activity of the ADAMTS13 enzyme (typically <10% of that in normal
plasma), leaving ultra-large vWF molecules un-cleaved (vWF is an important
protein involved in the blood clotting process). These ULvWF molecules
spontaneously bind to blood platelets, resulting in severe thrombocytopenia
(very low platelet count) and micro-clot formation in small blood vessels
throughout the body[2], resulting in thrombotic complications and widespread
organ damage[3].
aTTP is associated with major morbidities in the brain (e.g. stroke), heart and
kidney and impacts life expectancy and quality of life[4]. Mortality is high at
10-20%[5], typically occurring within 2 weeks after initial diagnosis. Moreover,
about 36% of patients have recurrences[6] after treatment with the current
standard of care, which consists of plasma exchange and immune-suppressants, and
these recurrences have the potential to cause further organ damage, thrombotic
complications and poorer longer term outcomes.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®,
proprietary therapeutic proteins based on single-domain antibody fragments,
which combine the advantages of conventional antibody drugs with some of the
features of small-molecule drugs. Ablynx is dedicated to creating new medicines
which will make a real difference to society. Today, the Company has more than
40 proprietary and partnered programmes in development in various therapeutic
areas including inflammation, haematology, immuno-oncology, oncology and
respiratory disease. The Company has collaborations with multiple pharmaceutical
companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck &
Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The
Company is headquartered in Ghent, Belgium. More information can be found on
www.ablynx.com.
For more information, please contact
Ablynx:
Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
e: edwin.moses(at)ablynx.com
Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch(at)ablynx.com
Follow us on Twitter (at)AblynxABLX
Ablynx media/analyst relations
FTI Consulting:
Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000
e: ablynx(at)fticonsulting.com
--------------------------------------------------------------------------------
[1] Press release June 2014; Manuscript in the NEJM, Feb 2014
[2] Veyradier, NEJM 2016: "von Willebrand Factor - A new target for TTP
treatment?"
[3] Scully et al, Br J Hem 2012; Sarode et al, J Clin Apher 2014; Chaturvedi et
al, Am J Hem 2013
[4] Deford Blood 2013
[5] Allford et al, BJH 2003, Kremer Hovinga, Blood 2010; Benhamou, Haematologica
2012; Goel et al Transfusion 2016
[6] George et al, EJB 2008
pdf format of the press release:
http://hugin.info/137912/R/2015551/747320.pdf
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via GlobeNewswire
[HUG#2015551]
Unternehmensinformation / Kurzprofil:
Datum: 26.05.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 473745
Anzahl Zeichen: 8275
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
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