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Phase IIb study to evaluate ALX-0061 monotherapy in adult patients
with active
rheumatoid arthritis (RA) who are intolerant to methotrexate, or for whom
methotrexate treatment is inappropriate

GHENT, Belgium, 7 April 2015 - Ablynx[Euronext Brussels: ABLX; OTC market:

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 (sc
) as a monotherapy in adult patients with active RA who are intolerant to
methotrexate (MTX), or for whom MTX is inappropriate. The study also aims to
obtain parallel descriptive information concerning the efficacy and safety of
administration ofsc
tocilizumab (Actemra®, RoActemra®) in the same RA population.

InSeptember 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 first Phase IIb study with ALX-0061 in combination with MTX in patients with active RA started on17 March 2015

This current Phase IIb study is a multi-centre, randomised study consisting of
two parallel treatment groups: a double-blind part to assess the efficacy and
safety of ALX-0061sc
and an open-label part (with a blinded independent joint-assessor) with
, which is not used as an active comparator but to provide parallel efficacy
and safety data for sc tocilizumab in the same RA patient population.

The study is expected to enrol 228 subjects in the United States, Europe and
South America, who will be randomly assigned to three different dose groups
of ALX-0061sc
or one dose group of tocilizumabsc
[1]. Administration of ALX-0061 will be performed every 2 weeks or every 4
weeks for 12 weeks. Subjects will be followed for efficacy up to week 12 and
for safety until 12 weeks after last dosing. Following completion of the
12-week dosing, eligible subjects will be invited to participate in an
open-label extension study.

The primary endpoint is the ACR20 response[2]of ALX-0061 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 of ALX-0061, documentation of efficacy of ALX-0061 over time, as
well as 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

Dr Edwin Moses, CEO of Ablynx, commented:

"Ablynx and our partner AbbVie are committed to developing ALX-0061 for people
living with rheumatoid arthritis. The start of this second Phase IIb study in
this chronic and progressive disease is therefore another important
milestone. We expect top line results from the two Phase IIb studies in RA
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 thein vivo
serum half-life. Phase I/II proof-of-concept results with ALX-0061 were published inFebruary 2013
, followed by the signing of a global exclusive licensing deal with AbbVie inSeptember 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

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

Ablynxis a biopharmaceutical company engaged in the development ofNanobodies®,
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 than30 proprietary and partnered programmesin 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

For more information, please contact


Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68

Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03

Follow us on Twitter @AblynxABLX

Ablynx media relations
Consilium Strategic Communications:

Mary-Jane Elliott, Jonathan Birt, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
---------------------------------------[1]Subjects will receive tocilizumab dosing regimen approved in their region:
1) US: 162 mg every 2 weeks (subjects weighing<100kg) or every week (for
subjects weighing more than or equal to 100 kg). 2) EU: 162 mg every week for
all subjects
[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


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Ablynx via Globenewswire


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