ABLYNX REPORTS POSITIVE PHASE I DATA FOR ALX-0061 IN RHEUMATOID ARTHRITIS
(Thomson Reuters ONE) -
GHENT, Belgium, 30 November 2011 - Ablynx [Euronext Brussels: ABLX] today
announced positive Phase I data from the single ascending dose part of the Phase
I/II study with ALX-0061, the anti-IL-6R Nanobody, in patients with rheumatoid
arthritis (RA). Based on these positive interim data, Ablynx has initiated a
multiple ascending dose Phase II study with ALX-0061 in patients with RA.
During the period April to September 2011, the Phase I study recruited a total
of 28 RA patients who received either placebo or a single dose of ALX-0061,
injected intravenously. The single doses ranged from 0.3 mg/kg to 6 mg/kg. The
study treatment was safe and well tolerated, and the biological effective doses
were achieved at the doses established in the pre-clinical studies. The dose-
dependent changes of the assessed biomarkers of early inflammation (C-reactive
protein, fibrinogen and platelets) were consistent with the inhibition of the
IL-6 pathway.
Following this study, three doses were selected for the Phase II study,
including 1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks, and 6 mg/kg every 8
weeks. This proof-of-concept Phase II study, which has been initiated today, is
expected to recruit 36 RA patients. A first read out, including efficacy
measures (DAS, ACR scores) is anticipated after 12 weeks and a final read out,
including biomarker responses, is planned after 24 weeks.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "The rapid progress and
the positive results from this first part of the Phase I/II study with ALX-0061
in RA patients gave us confidence to progress our IL-6R programme into the
multiple ascending dose part of this study. We are on track to potentially
achieve clinical proof-of-concept by the end of 2012." He added: "Now together
with the rights to the anti-TNF-alpha Nanobodies which we have recently
recovered, we believe we have an increasingly strong portfolio in inflammation,
which includes a number of clinical assets with various modes of action that
have the potential to address the complexity of RA and other autoimmune
diseases, as not all patients adequately respond to current drugs."
About ALX-0061 (anti-IL-6R)
ALX-0061 is a Nanobody binding to the interleukin-6 receptor (IL-6R). It has the
potential to be differentiated from the benchmark monoclonal antibody through
its high potency, high stability and low molecular weight of only 26kD which
could translate into superior tissue penetration, attractive PK/PD and a
superior safety and efficacy profile. The Nanobody is half-life extended with a
Nanobody targeting albumin, which is believed to improve the delivery of the
Nanobody to inflamed tissues.
The involvement of the IL-6 pathway in a variety of diseases indicates that
multiple indications can be pursued with large market potential including
rheumatoid arthritis (RA), Crohn's disease, Castleman's disease, multiple
myeloma and systemic lupus erythematosus (SLE).
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
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch(at)ablynx.com
Complete version of the press release:
http://hugin.info/137912/R/1567677/487081.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters 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 Thomson Reuters ONE
[HUG#1567677]
Unternehmensinformation / Kurzprofil:
Datum: 30.11.2011 - 18:00 Uhr
Sprache: Deutsch
News-ID 92682
Anzahl Zeichen: 4434
contact information:
Town:
Ghent
Kategorie:
Business News
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