ABLYNX REPORTS COMPELLING TOPLINE PHASE IIb STUDY RESULTS WITH ITS ANTI-IL-6R NANOBODY, VOBARILIZUMAB, IN RA PATIENTS, CONFIRMING ITS BEST-IN-CLASS POTENTIAL
(Thomson Reuters ONE) -
* ACR20, ACR50 and ACR70 scores of up to 79%, 59% and 43% respectively at week
24
* Strong impact on disease activity with up to 49% of patients in clinical
remission at week 24
* Excellent safety profile at all administered doses
* Opportunity for convenient monthly dosing confirmed
* Results demonstrate clear potential advantages of vobarilizumab compared to
other anti-IL-6/IL-6R drugs
Conference call and webcast today at 4pm CET/10am ET
GHENT, Belgium, 9 August 2016 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY]
today announced compelling topline results from a second Phase IIb RA study with
its anti-IL-6R Nanobody®, vobarilizumab, which showed that treatment with
vobarilizumab strongly decreased signs and symptoms of rheumatoid arthritis (RA)
in patients with moderate to severe disease already being treated with
methotrexate (MTX).
The double-blind study enrolled 345 subjects in Europe, Latin America and the
United States, who were randomly assigned to one of the four dose groups of
subcutaneously (sc) administered vobarilizumab plus methotrexate [75 mg every 4
weeks (Q4W), 150 mg Q4W, 150 mg Q2W, 225 mg Q2W] or placebo plus methotrexate.
Subjects were evaluated for efficacy up to and including week 24 and for safety
up to and including week 34. Following completion of the 24-week treatment
period, eligible subjects were invited to enroll in an open-label extension
study of vobarilizumab, with 94% accepting. Subjects who were not eligible to
roll over or who did not elect to do so were followed for safety for an
additional 12 weeks after the last dosing. Evaluation is ongoing for a minority
of these subjects.
At week 12, a 20% improvement in American College of Rheumatology scores
(ACR20), the primary endpoint of the study, was seen in up to 81% of
vobarilizumab-treated patients. From week 12 to week 24, vobarilizumab induced
continued improvement in higher level responses with ACR50 and ACR70 scores of
up to 59% and 43% respectively at week 24. Moreover, the results demonstrate
that vobarilizumab has a rapid and strong impact on disease activity with up to
49% of vobarilizumab-treated patients achieving clinical remission at week 24
compared to 17% of patients receiving placebo.
A summary of the efficacy results in the intent-to-treat (ITT) population is
presented below:
% responders based on ITT analysis with non-responder imputation
+------------+-------+-------------+----------------+-----------------+-----------------+
| |placebo|vobarilizumab| vobarilizumab | vobarilizumab | vobarilizumab |
|Efficacy | | 75mg, Q4W | 150mg, Q4W | 150mg, Q2W | 225mg, Q2W |
|parameter |(N=69) | (N=69) | (N=70) | (N=68) | (N=69) |
| +---+---+---+---------+--------+-------+--------+--------+--------+--------+
| |W12|W24|W12| W24 | W12 | W24 | W12 | W24 | W12 | W24 |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
|ACR20[1] |62%|74%|75%| 74% | 81%(*) | 79% | 78% | 72% | 72% | 74% |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
|ACR50(1) |28%|39%|29%| 48% | 44% | 56% | 41% | 54% | 45% | 59%(*) |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
|ACR70(1) |9% |17%|14%| 23% | 21% | 33% | 19% | 22% | 17% |43%(**) |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
|Clinically | | | | | | | | | | |
|meaningful | | | | | | | | | | |
|improvement | | | | | | | | | | |
|in HAQ-DI |71%|71%|68%| 68% | 71% | 67% | 69% | 68% | 65% | 65% |
|score | | | | | | | | | | |
|(greater or | | | | | | | | | | |
|equal than | | | | | | | | | | |
|0.25)[2] | | | | | | | | | | |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
|DAS28(CRP) |9% |17%|10%| 23% |37%(***)|37%(*) |35%(***)|38%(**) | 25%(*) |49%(***)|
|remission[3]| | | | | | | | | | |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
|DAS28(CRP) | | | | | | | | | | |
|low disease |23%|29%|25%| 38% |53%(***)|57%(**)|47%(**) |60%(***)|57%(***)|68%(***)|
|activity or | | | | | | | | | | |
|remission(3)| | | | | | | | | | |
+------------+---+---+---+---------+--------+-------+--------+--------+--------+--------+
*nominal p<0.05 vs. placebo; **nominal p<0.01 vs. placebo; ***nominal p<0.001
vs. placebo
The interim safety results through week 24 confirm vobarilizumab's excellent
safety profile which offers the potential for a clear competitive advantage over
other anti-IL-6/IL-6R drugs. Treatment-emergent adverse events that led to study
drug discontinuation were reported in 6.5% of all vobarilizumab treated patients
compared to 4.3% for placebo. Treatment-related serious adverse events were
reported in only 1.8% of all vobarilizumab treated patients compared to 2.9% for
placebo and there was no observed dose dependency. Clinically meaningful
abnormalities in liver function and neutrophil counts were infrequent across the
study. Moreover, no grade 3 decreases in absolute platelet counts[4] were
observed and vobarilizumab had no effect on the mean LDL/HDL cholesterol ratio
across all doses tested.
Dr Robert K. Zeldin, CMO of Ablynx, commented: "We are pleased to have
successfully completed the second Phase IIb study with vobarilizumab in RA
patients which showed that it has a meaningful impact on stringent and
clinically relevant efficacy criteria such as ACR70 and DAS28 remission, and
which confirmed vobarilizumab's very favourable safety profile in a larger
patient population. In addition, we were delighted to demonstrate the potential
for monthly administration of vobarilizumab which could be very beneficial to
patients. Together with the positive results from the RA monotherapy trial
reported last month, we believe we have a most compelling data set underlining
the potential for vobarilizumab to become a best-in-class, differentiated
treatment option for patients suffering from RA."
Dr Edwin Moses, CEO of Ablynx, commented: "From 2012/2013 when we saw the first
results from the Phase IIa study with vobarilizumab in RA patients, we have been
convinced that we have a drug with the potential to make an important difference
to the lives of patients suffering from RA. Having entered into a collaboration
with AbbVie in 2013 to help ensure the proper resourcing of clinical and
commercial development, we are excited to have now confirmed that vobarilizumab
has potential efficacy, safety and administration advantages compared to the
competition. We believe that these results and those from many other Nanobody
therapeutic programmes emphasize the fact that Nanobodies are not just another
type of antibody but rather a whole new class of powerful therapeutic agents
with important promotable differentiating features compared with other
platforms. We now look forward to initiating the Phase III programme with
vobarilizumab and AbbVie's decision on whether they will opt into this programme
in RA, which we expect before the end of the year."
Webcast and presentation
Ablynx will host a conference call/webcast today at 4 pm CET, 10 am EST. The
webcast may be accessed by clicking here. To participate in the Q&A, please dial
+32 (0)2 404 06 60, using confirmation code 3494034. Shortly thereafter, a
replay of the webcast will be available on the Company's website:
http://www.ablynx.com/news/events-presentations/.
About the Phase IIb RA combination therapy study
This Phase IIb study is a randomised, double-blind, placebo-controlled, multi-
centre, dose-ranging study of vobarilizumab, administered subcutaneously in
combination with MTX in subjects with moderate to severe RA, despite MTX
therapy.
The study enrolled 345 subjects in Europe, Latin America and the United States,
who were randomly assigned to placebo plus MTX or one of the four dose groups of
vobarilizumab administered subcutaneously plus MTX. Subjects were evaluated for
efficacy up to and including week 24 and for safety up to and including week
34. Following completion of the 24-week study, eligible subjects were then
invited to enroll in an open-label extension study, with 94% accepting.
The primary endpoint is the ACR20 response at week 12. In accordance with the
study protocol, any subject who did not achieve a 20% improvement from baseline
in both swollen and tender joint count at any of the visits at week 12, 16 or
20 had to discontinue from the trial - this was an unusual requirement brought
about by the desire to carry out a 24-week study with sc vobarilizumab for which
there was only limited supporting data available. The secondary endpoints
include higher levels of response assessments, documentation of efficacy over
time, as well as the effects on the improvement in physical function and health-
related quality of life. Other planned assessments include the determination of
serum levels of vobarilizumab, biomarkers, safety, tolerability and
immunogenicity.
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 the in 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 in February
2013, followed by the signing of a global exclusive option licensing deal with
AbbVie in September 2013 for the development and commercialisation of
vobarilizumab in RA and systemic lupus erythematosus (SLE).
In July 2016, Ablynx announced positive Phase IIb topline results for
vobarilizumab as a monotherapy in patients with moderate to severe RA who were
intolerant to methotrexate or for whom continued methotrexate treatment was
inappropriate, demonstrating ACR20, ACR50 and ACR70 scores of up to 81%, 49% and
24% respectively at week 12. In addition, vobarilizumab as a monotherapy induced
clinical remission in up to 41% of patients and had a favourable safety profile
at all doses tested.
An open-label extension study in RA patients is currently ongoing as well as a
Phase II study in patients with systemic lupus erythematosus (SLE). The results
from both these studies are expected in 2018.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®,
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 than
40 proprietary and partnered programmes in 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 on
www.ablynx.com.
For more information, please contact
Ablynx:
Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
e: edwin.moses(at)ablynx.com
Marieke Vermeersch
Director IR & Corporate Communications
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch(at)ablynx.com
Follow us on Twitter (at)AblynxABLX
Ablynx media/analyst relations
FTI Consulting:
Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000
e: ablynx(at)fticonsulting.com
--------------------------------------------------------------------------------
[1] ACR criteria measure improvement in tender and swollen joint counts and
improvement in three of five other disease-activity measures; ACR20 measures %
of patients with 20% improvement; ACR50 measures % of patients with 50%
improvement and ACR70 measures % of patients with 70% improvement
[2] HAQ-DI, health assessment questionnaire disability score for RA. Wolfe F. et
al, Arthritis & Rheumatism, Vol. 42, No. 9, September 1999, pp 1797-1808
[3] DAS28(CRP) is an objective RA disease activity score based on C-reactive
protein (CRP), tender and swollen joint counts of 28 defined joints and
patient's global assessment of disease activity; a score of >5.1 is associated
with high disease activity, 5.1 to 3.2 moderate disease activity, 3.2 to 2.6 low
disease activity, and <2.6 is associated with remission
[4] Grade 3: absolute platelet count of <50.0 to 25.0 x 10(9)/L
pdf format of the press release:
http://hugin.info/137912/R/2033916/757410.pdf
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GlobeNewswire 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 GlobeNewswire
[HUG#2033916]
Unternehmensinformation / Kurzprofil:
Datum: 09.08.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 487883
Anzahl Zeichen: 16110
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
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