YASTEST
GHENT, Belgium,
21 November 2017 (3.30pm CET) - Ablynx NV [Euronext Brussels and
Nasdaq: ABLX] today announced that results from its Phase III
HERCULES study of caplacizumab have been selected as one of only
six abstracts for oral presentation in the late-breaking abstracts
session at the 59th Annual
Meeting of the American Society of Hematology (ASH) taking place in
Atlanta, GA, on 12 December 2017.
Caplacizumab is Ablynx's
wholly-owned anti-von Willebrand factor (vWF) Nanobody® being
developed for the treatment of acquired thrombotic thrombocytopenic
purpura (aTTP). Positive topline results from the Phase III
HERCULES study, meeting primary and two key secondary endpoints,
were announced on 2 October 2017.
The abstract (LBA-1), "Results of
the Randomized, Double-Blind, Placebo-Controlled, Phase III
HERCULES study of Caplacizumab in Patients with Acquired Thrombotic
Thrombocytopenic Purpura", will be presented by Professor Marie
Scully, M.D., Department of Haematology, University College London
Hospitals NHS Trust, London, UK.
The abstract is available at
https://ash.confex.com/ash/2017/webprogram/Paper109057.html and
will be included in the 8 December online issue of Blood.
Commenting on today's
announcement, Dr Edwin Moses, CEO of Ablynx, said: "We are very
pleased that our positive Phase III HERCULES data have been
accepted for this presentation at the world's leading hematology
conference, the 2017 ASH Annual Meeting in Atlanta, USA. The data
confirm the significant potential of caplacizumab for patients with
aTTP for whom there is currently no approved therapeutic drug
available."
Session
Information
Name: Late-Breaking Abstracts
Session
Date: Tuesday 12 December 2017
Time: 7:30 AM - 9:00 AM ET
Presentation Time: 7:30 AM ET
Room: Building C, Level 1, Hall C2-C3 (Georgia World Congress
Center)
About
HERCULES
The HERCULES study recruited 145
patients and is the largest randomised, double-blind,
placebo-controlled study conducted in patients with aTTP. Patients
with an acute episode of aTTP were randomised 1:1 to receive either
caplacizumab or placebo in addition to daily plasma exchange (PEX)
and immunosuppression. Patients received a single intravenous bolus
of 10mg caplacizumab or placebo followed by a daily subcutaneous
dose of 10mg caplacizumab or placebo for 30 days after the last
daily PEX. If at the end of this treatment period there was
evidence of persistent underlying disease activity (indicative of
an imminent risk for recurrence), treatment could be extended for
additional seven-day periods up to a maximum of 28 days and was to
be accompanied by optimisation of immunosuppression. Patients were
followed for a further 28 days after discontinuation of
treatment.
A three-year follow-up study
(NCT02878603) of patients who have completed the HERCULES study is
in progress and will further evaluate the long-term safety and
efficacy of caplacizumab and repeated use of caplacizumab, as well
as characterising the long-term impact of aTTP.
About
caplacizumab
Caplacizumab is a bivalent
anti-vWF Nanobody that received Orphan Drug Designation in Europe
and the United States in 2009. Caplacizumab blocks the interaction
of ultra-large vWF multimers (ULvWF) with platelets and, therefore,
has an immediate effect on platelet aggregation and the ensuing
formation and accumulation of the micro-clots that cause the severe
thrombocytopenia, tissue ischemia and organ dysfunction in aTTP.
This immediate effect of caplacizumab has the potential to protect
the patient from the manifestations of the disease while the
underlying disease process resolves.
In February 2017, based on the
Phase II study results, a Marketing Authorisation Application (MAA)
was submitted to the European Medicines Agency (EMA) for approval
of caplacizumab in aTTP. In July 2017, Ablynx received Fast Track
designation from the Food and Drug Administration (FDA) for
caplacizumab for the treatment of aTTP. In October 2017,
positive results from the Phase III HERCULES study, meeting primary
and two key secondary endpoints, were announced. These data are
expected to further support the MAA, as well as a planned Biologics
License Application (BLA) filing in the United States in 2018. If
approved by regulatory authorities, caplacizumab would be the first
therapeutic specifically indicated for the treatment of aTTP.
About
aTTP
aTTP is a rare, acute,
life-threatening, autoimmune blood clotting disorder. It is caused
by impaired activity of the ADAMTS13 enzyme, leaving ULvWF
molecules uncleaved (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 clot formation in small blood vessels
throughout the body[1], leading to
ischemia and widespread organ damage[2].
Despite the current
standard-of-care treatment consisting of PEX and immunosuppression,
episodes of aTTP are still associated with a mortality rate of up
to 20%, with most deaths occurring within 30 days of
diagnosis[3].
Furthermore, patients are at risk of acute thromboembolic
complications (e.g. stroke, myocardial infarction) and of
recurrence of disease. Some patients are refractory to
therapy1, which is
associated with a poor prognosis for survival of an acute episode
of aTTP. Long term, patients are at increased risk for
hypertension, major depression, and premature death[4].
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 45 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; Merck & Co., Inc., Kenilworth, New Jersey, USA;
Merck KGaA; Novartis; Novo Nordisk; Sanofi 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@ablynx.com
Lies Vanneste
Director Investor Relations
t: +32 (0)9 262 01 37
m: +32 (0)498 05 35 79
e: lies.vanneste@ablynx.com
Follow us on Twitter @AblynxABLX
Ablynx media
relations:
Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Sukaina Virji
t: +44 (0)20 3709 5700
e: ablynx@consilium-comms.com
[1] Veyradier,
NEJM 2016: "von Willebrand Factor - A new target for TTP
treatment?"
[2] Scully
et al., Br J Hem 2012; Sarode et al., J Clin Apher 2014; Chaturvedi et al., Am J Hem 2013
[3] Benhamou,
Y. et al., Haematologica 2012
[4] Deford
et al., Blood 2013
pdf version of the press
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information contained therein.
Source: Ablynx via Globenewswire
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