GHENT, BELGIUM--(Marketwire - November 30, 2011) -
GHENT, Belgium, 30 November 2011 - Ablynx [Euronext Brussels: ABLX]
announced positive Phase I data from the single ascending dose part of the
I/II study with ALX-0061, the anti-IL-6R Nanobody, in patients with
arthritis (RA). Based on these positive interim data, Ablynx has
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
of 28 RA patients who received either placebo or a single dose of ALX-
injected intravenously. The single doses ranged from 0.3 mg/kg to 6
study treatment was safe and well tolerated, and the biological effective
were achieved at the doses established in the pre-clinical studies. The
dependent changes of the assessed biomarkers of early inflammation (C-
protein, fibrinogen and platelets) were consistent with the inhibition
Following this study, three doses were selected for the Phase II
including 1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks, and 6 mg/kg
weeks. This proof-of-concept Phase II study, which has been initiated
expected to recruit 36 RA patients. A first read out, including
measures (DAS, ACR scores) is anticipated after 12 weeks and a final read
including biomarker responses, is planned after 24 weeks.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "The rapid
the positive results from this first part of the Phase I/II study with ALX-
in RA patients gave us confidence to progress our IL-6R programme
multiple ascending dose part of this study. We are on track to
achieve clinical proof-of-concept by the end of 2012." He added: "Now
with the rights to the anti-TNF-alpha Nanobodies which we have
recovered, we believe we have an increasingly strong portfolio in
which includes a number of clinical assets with various modes of action
have the potential to address the complexity of RA and other
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
potential to be differentiated from the benchmark monoclonal antibody
its high potency, high stability and low molecular weight of only 26kD
could translate into superior tissue penetration, attractive PK/PD
superior safety and efficacy profile. The Nanobody is half-life extended
Nanobody targeting albumin, which is believed to improve the delivery
Nanobody to inflamed tissues.
The involvement of the IL-6 pathway in a variety of diseases indicates
multiple indications can be pursued with large market potential
rheumatoid arthritis (RA), Crohn's disease, Castleman's disease,
myeloma and systemic lupus erythematosus (SLE).
Complete version of the press release:
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Source: Ablynx via Thomson Reuters ONE