ABLYNX INITIATES THE FIRST OF TWO PHASE IIb RA STUDIES WITH ITS ANTI-IL-6R NANOBODY, PARTNERED WITH ABBVIE
(Thomson Reuters ONE) -
Phase IIb study to evaluate ALX-0061, in combination with methotrexate, in
adult patients with moderate to severe rheumatoid arthritis (RA)
GHENT, Belgium, 17 March 2015 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY]
today announced that it has administered the first dose in the Phase IIb study
to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061,
administered subcutaneously in combination with methotrexate (MTX) in adult
patients with active RA, despite MTX therapy. The study aims to identify the
optimum dose and frequency of administration of ALX-0061 for the next phases of
development.
In September 2013, Ablynx and AbbVie entered into a global license agreement,
worth up to US$840 million plus double-digit royalties, to develop and
commercialise ALX-0061. As part of the agreement, Ablynx is responsible for
Phase II clinical development of ALX-0061 in both RA and systemic lupus
erythematosus (SLE).
The current Phase IIb study is a multi-centre, randomised, double-blind,
placebo-controlled dose-range finding study of ALX-0061, administered
subcutaneously in combination with MTX (a commonly used first-line DMARD[1]
agent for patients with RA), in subjects with moderate to severe RA, despite MTX
therapy. The study is expected to enrol 330 subjects in the United States,
Europe and South America, who will be randomly assigned to placebo or four
different dose groups of ALX-0061 administered subcutaneously. Administration
will be performed every 2 weeks or every 4 weeks. Subjects will be followed for
efficacy up to and including week 24 and for safety up to and including week
34. Following completion of the 24-week study, eligible subjects will be invited
to participate in an open-label extension study.
The primary endpoint is the ACR20 response[2] at week 12, a broadly accepted
clinical response measure to demonstrate reduction in RA signs and symptoms. The
secondary endpoints include higher level of response assessments, documentation
of efficacy of ALX-0061 over time, as well as of the effects of ALX-0061 on the
improvement in physical function and health-related quality of life. Other
planned assessments include the determination of ALX-0061 levels, biomarkers,
safety, tolerability and immunogenicity.
Dr Edwin Moses, CEO of Ablynx, commented:
"Ablynx and our partner AbbVie are committed to making ALX-0061 available for
people living with rheumatoid arthritis. The start of this first Phase IIb study
in this chronic and progressive disease is therefore an important milestone. The
programme is progressing according to plan and we expect top line results from
the study before the end of 2016. If the results meet pre-defined success
criteria, AbbVie will exercise its right to in-license ALX-0061 and be
responsible for subsequent Phase III clinical development and
commercialisation."
About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and has
been developed for the treatment of RA and possibly systemic lupus erythematosus
(SLE). IL-6 is a pro-inflammatory cytokine that plays a role in T-cell
activation, production of acute phase proteins in response to inflammation,
induction of immunoglobulin production, and stimulation of osteoclast
differentiation and activation. ALX-0061 (26kD) has a very strong affinity for
the soluble IL-6R and contains an anti-IL-6R Nanobody linked to an anti-human
serum albumin (HSA) Nanobody, thereby increasing the in vivo serum half-life.
Phase I/II proof-of-concept results with ALX-0061 were published in February
2013, followed by the signing of a global exclusive licensing deal with AbbVie
in September 2013 for the development and commercialisation of ALX-0061.
About RA and SLE
RA is characterised by chronic and progressive joint inflammation that typically
results in permanent, debilitating tissue damage, which is further compounded by
joint deformation. The condition is associated with lower quality of life,
premature death, disability, and unemployment. It is estimated that up to 1
percent of the adult population worldwide suffer from RA.
SLE is a complex, multi-organ, autoimmune disorder characterised by the
production of pathogenic autoantibodies and tissue deposition of immune
complexes, which result in widespread tissue damage. Although the aetiology of
SLE is not fully understood, multiple genetic, environmental, and hormonal
factors have been implicated in its development. The disease displays a broad
variety of symptoms and highly variable clinical features, including systemic,
cutaneous, renal, musculoskeletal, and haematological manifestations.
Approximately 5 million people worldwide suffer from a form of lupus and 90
percent of people diagnosed are women.
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
30 proprietary and partnered programmes in development in various therapeutic
areas including inflammation, haematology, oncology and respiratory disease. The
Company has collaborations with multiple pharmaceutical companies including
AbbVie, Boehringer Ingelheim, Merck & Co., Inc, Merck Serono and Novartis. 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 relations Consilium Strategic Communications:
Mary-Jane Elliott, Jonathan Birt, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
e: ablynx(at)consilium-comms.com
--------------------------------------------------------------------------------
[1] DMARD: disease modifying anti-rheumatic drug
[2] ACR (American College of Rheumatology) responses measure improvements in
tender and swollen joint counts and improvements in three of five other disease-
activity measures. To achieve an ACR20 the patients must show an improvement of
at least 20%.
pdf format of the press release:
http://hugin.info/137912/R/1903814/677119.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
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#1903814]
Unternehmensinformation / Kurzprofil:
Datum: 17.03.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 378899
Anzahl Zeichen: 8119
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 212 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"ABLYNX INITIATES THE FIRST OF TWO PHASE IIb RA STUDIES WITH ITS ANTI-IL-6R NANOBODY, PARTNERED WITH ABBVIE"
steht unter der journalistisch-redaktionellen Verantwortung von
Ablynx (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
