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Data from the Phase IIb study in patients with moderate-to-severe disease
already being treated with methotrexate to be presented at the Canadian
Rheumatology Association (CRA) Annual Scientific Meeting

GHENT, Belgium, 9 February 2017
-Ablynx[Euronext Brussels: ABLX; OTC: ABYLY]

announced that today it will present additional data from the Phase IIb RA
combination study of its anti-IL-6R Nanobody®, vobarilizumab, at the Annual
Scientific Meeting of the Canadian Rheumatology Association, being held from
8-11 February 2017 in Ottawa, Ontario (Canada). These data will be presented
in two posters which will be available on the Ablynx website shortly after
the conference.

In this 24-week, double-blind, international study, patients were randomised
to receive subcutaneously administered placebo or one of four dose regimens
of vobarilizumab, in addition to methotrexate. The primary endpoint was the
proportion of patients achieving an ACR20 response at week 12. The secondary
endpoints included assessments of higher levels of ACR response and disease
activity (DAS28CRP). Adverse events and routine safety parameters including
laboratory assessments were also recorded.

The data show that in patients with active RA despite use of methotrexate,
treatment with vobarilizumab (150mg q4w, 150mg q2w and 225mg q2w) had a
positive impact on disease activity with a compelling safety profile.
Overall, the results support the advancement of vobarilizumab into Phase III

About vobarilizumab

Vobarilizumab targets the interleukin 6 pathway via its IL-6 receptor (IL-6R). 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. Vobarilizumab (26kD) is an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody (to increase thein vivo
half-life of the molecule). Twenty-four-week data from a Phase I/IIa proof-of-concept study of ALX-0061 (vobarilizumab) in combination with methotrexate were published inFebruary 2013
, followed by the signing of a global exclusive option licensing deal with AbbVie inSeptember 2013
for the development and commercialisation of vobarilizumab in RA and systemic lupus erythematosus (SLE).

InJuly 2016
, Ablynx announced strong topline results from a 12-week Phase IIb study of vobarilizumab as a monotherapy in patients with moderate-to-severe RA which demonstrated that vobarilizumab was very effective and resulted in ACR20, ACR50 and ACR70 scores of up to 81%, 49% and 24% respectively at week 12. Moreover, vobarilizumab induced clinical remission (based on DAS28CRP<2.6) in up to 41% of patients, as compared to 27% for tocilizumab-treated patients, and it had a favourable safety profile at all administered doses.

InAugust 2016
, Ablynx reported compelling results from a 24-week Phase IIb study of vobarilizumab administered as a combination therapy with methotrexate (MTX) in patients with moderate-to-severe RA. ACR20, ACR50 and ACR70 scores at week 24 were high and vobarilizumab had a rapid and strong impact on disease activity with up to 49% of vobarilizumab-treated patients achieving clinical remission (based on DAS28CRP) at week 24.

Collectively the impressive effects on clinically relevant efficacy endpoints,
such as ACR70 and DAS28 remission, confirm its potential to be a
best-in-class drug candidate in RA. Importantly, the collective results also
confirmed the favourable safety profile of vobarilizumab in a larger patient
population and the potential for convenient monthly administration.

An open-label extension study in RA patients is currently ongoing (94%
roll-over rate) as well as a Phase II study in patients with systemic lupus
erythematosus (SLE). The results from both of these studies are expected in

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 than45 proprietary and partnered programmesin development in various
therapeutic areas including inflammation, haematology, immuno-oncology,
oncology and respiratory disease. The Company has collaborations with
multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim,
Eddingpharm, Merck&Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho
Pharmaceuticals. 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
Director IR&Corporate Communications
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03

Follow us on Twitter @AblynxABLX

Ablynx media/analyst relations

FTI Consulting:

Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000

pdf format of the press release

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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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