ABLYNX TO PRESENT RHEUMATOID ARTHRITIS DATA AT 2012 AMERICAN COLLEGE OF RHEUMATOLOGY ANNUAL MEETING
(Thomson Reuters ONE) -
GHENT, Belgium, 9 November 2012 - Ablynx [Euronext Brussels: ABLX] today
announced that it will present data from two Nanobody®-based products in
rheumatoid arthritis (RA) at the annual meeting of the American College of
Rheumatology (ACR) from 10-14 November in Washington D.C., USA. The poster
presentations will be based on the outcome of pre-clinical and clinical studies
that have previously been disclosed.
Ablynx will have three poster sessions including two posters on its novel IL-6R
Nanobody, ALX-0061, and one poster on its novel anti-TNFa Nanobody, ozoralizumab
(ATN-103).
ALX-0061 is a bi-specific IL-6R targeting Nanobody with monovalent binding to
IL-6R and human serum albumin. Translational modelling studies resulted in a
novel first-in-human design that combined a single-ascending dose, a multiple
ascending dose and clinical POC using pharmacokinetics, biomarker and early
clinical read outs as decision tools. Earlier reported results from the 12 week
interim analysis of the Phase I/II study demonstrate that ALX-0061 has the
potential to become a best-in-class IL-6R inhibitor in RA with a strong efficacy
profile based on a 80% ACR20 response, a 60% DAS28-CRP remission rate, and a
fast onset of DAS28-CRP remission; and an excellent safety profile with no
serious infections, no decrease in neutrophils, no clinically significant
increases in liver enzymes and no increases in lipid levels (cholesterol and
LDL) being observed.
Ozoralizumab, ATN-103, a novel TNFa inhibitor, is a trivalent, bi-specific
Nanobody that potently neutralises TNF and binds to human serum albumin to
increase its in vivo half-life. The results from the Phase II open-label
extension study demonstrated that ozoralizumab enables highly effective and
well-tolerated individualised treatment. The specific molecular features of
Nanobodies, including their small size, low immunogenic potential and
manufacturability, contributed to the desired outcome, with the majority of
patients showing marked improvement in their disease activity. Moreover, the
once-induced remission could be maintained at doses less than 80mg monthly. This
treatment approach could be beneficial to patients and minimise treatment costs.
Details on the poster sessions
Abstract/poster #336: Pre-clinical development of ALX-0061, an anti-IL-6R
Nanobody for therapeutic use in rheumatoid arthritis with a high in vitro
affinity and potency and a competitive in vivo pharmacological profile - 11
November
Abstract/poster #1307: Anti-IL-6 receptor Nanobody (ALX-0061) seamless "first-
in-human" Phase I/II POC study in patients with active RA on stable MTX
treatment- 12 November
Abstract/poster #1311: A novel individualised treatment approach in open-label
extension study of ozoralizumab (ATN-103) in subjects with rheumatoid arthritis
on a background of methotrexate - 12 November
About Ablynx
Ablynx is a biopharmaceutical company engaged in the discovery and development
of Nanobodies(®), a novel class of therapeutic proteins based on single-domain
antibody fragments, for a range of serious human diseases, including
inflammation, haematology, oncology and pulmonary disease. Today, the Company
has approximately 25 programmes in the pipeline and seven Nanobodies at clinical
development stage. Ablynx has ongoing research collaborations and significant
partnerships with major pharmaceutical companies including Boehringer Ingelheim,
Merck KGaA, Novartis and Merck & Co. 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
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(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
M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: ablynx(at)mcomgroup.com
press release in pdf:
http://hugin.info/137912/R/1656461/535559.pdf
This announcement is distributed by Thomson Reuters on behalf of
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(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 Thomson Reuters ONE
[HUG#1656461]
Unternehmensinformation / Kurzprofil:
Datum: 09.11.2012 - 08:00 Uhr
Sprache: Deutsch
News-ID 201538
Anzahl Zeichen: 5363
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
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