Bli medlem
Bli medlem

Du är här



* AbbVie has decided at this time not to exercise its right to opt-in and
license vobarilizumab in RA
* Additional analysis of the Phase IIb RA studies of vobarilizumab further
demonstrate its best-in-class efficacy and safety profile
* Ablynx will now rapidly move vobarilizumab into a Phase III RA programme
while initiating partnering discussions

Webcast presentation, including additional results from the Phase IIb RA
studies of vobarilizumab, will take place today at 4pm CET/10am EST (details
below) - slides available on the Ablynx website

R&D portfolio)

GHENT, Belgium, 20 October 2016
-Ablynx[Euronext Brussels: ABLX; OTC: ABYLY]

today announced that it will initiate the processes for End-of-Phase II and
scientific advice meetings with the regulators in the USA and Europe (FDA and
EMA[1]) for its anti-IL-6R Nanobody®, vobarilizumab, as part of the
preparations to start Phase III clinical development in patients with
rheumatoid arthritis (RA).

In two Phase IIb RA studies in 596 patients, vobarilizumab was shown to have a
strong and sustained effect on signs and symptoms of disease, with an
excellent safety and tolerability profile[2]. As a monotherapy, in a
head-to-head study, vobarilizumab was much more efficacious compared to
tocilizumab (the only currently approved anti-IL-6R drug) with up to 60% more
patients in clinical remission at week 12. In combination with methotrexate,
in a cross study analysis, vobarilizumab had an excellent efficacy profile
based on the most stringent efficacy parameters (ACR70; remission) as
compared to the leading commercial biologicals and oral anti-RA drugs in
development. A class advantage of vobarilizumab versus antibodies was also
demonstrated, with anti-drug antibodies having no effect on clinical efficacy
and safety in contrast to the experience with some of the most established
antibody products in RA.

Dr Edwin Moses, CEO of Ablynx, explained
: "We are obviously disappointed that AbbVie has decided at this time not to
exercise its right to license vobarilizumab in RA. The strong Phase IIb
results in RA demonstrated that vobarilizumab is not just another antibody
but a member of a new therapeutic class with unique differentiating features
resulting in a superior efficacy and safety profile as compared to other
biologicals. We are absolutely committed to progressing this programme and
will therefore start the preparations for the Phase III study with the first
patients expected to be enrolled by the end of 2017. I have great confidence
in our clinical team's proven ability to prepare and implement our Phase III
plan while we identify a committed partner for the future development and
commercialisation of the product. In addition, we will complete the ongoing
Phase II study with vobarilizumab in SLE patients, for which results are
anticipated in the first half of 2018."

Webcast and conference call

Ablynx will host a conference call/webcast today at 4 pm CET, 10 am EST during
which additional results from the Phase IIb RA studies of vobarilizumab and
the next steps in the development plan will be presented. The webcast and
presentation may be accessed by clickinghere. A copy of the presentation is
also available on the Ablynx website, under theR&D portfoliosection. To
participate in the Q&A, please dial +32 (0)2 404 06 60, using confirmation
code 6916752.

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). 24-week data from a Phase I/IIa proof-of-concept combination study of ALX-0061 (vobarilizumab) together 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 the 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[3]) 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 the 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 were 79%, 59% and 43% respectively at week 24, and vobarilizumab had a rapid and strong impact on disease activity with up to 49% of vobarilizumab-treated patients achieving clinical remission (based on DAS28CRP1) at week 24. Whilst the primary endpoint of a statistically significant difference in the number of patients who achieved an ACR20 at week 12 with vobaralizumab plus methotrexate compared to placebo plus methotrexate was not achieved due to an unusually high placebo response, this has no impact on the future development potential for vobarilizumab since its impressive effect 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 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 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, Genzyme, 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
---------------------------------------[1]FDA: Food and Drug Administration; EMA: European Medicines Agency
[2]Press releasesJuly
2016; presentation additional Phase IIb results available on the Ablynxwebsite
[3]Remission: DAS28CRP<2.6

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

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.