REGULATED INFORMATION - INSIDE
INFORMATION
GHENT, Belgium,
26 March 2018 - Ablynx [Euronext Brussels and
Nasdaq: ABLX] today announced that the Phase II dose-ranging
study of vobarilizumab, the Company's anti-IL-6R Nanobody®, did not
meet the primary endpoint of dose response based on the modified
BILAG-based combined lupus assessment (mBICLA) at Week 24.
The study enrolled 312 patients
with moderate to severe, active seropositive systemic lupus
erythematosus (SLE) across five treatment arms (four dose regimens
of vobarilizumab and placebo). Demographics and baseline
characteristics were similar across treatment arms, and reflective
of a typical SLE population.
Safety findings through Week 58
were favourable for vobarilizumab. Treatment-related serious
adverse events were reported in 2.0% of all vobarilizumab treated
patients compared to 6.5% in the placebo group. The percentage of
patients experiencing a serious infection was also lower in the
vobarilizumab arms compared to the placebo arm (2.8% versus 6.5%).
Treatment-emergent adverse events that led to study drug
discontinuation were reported in 12.4% of all vobarilizumab treated
patients compared to 6.5% in the placebo group. Two deaths were
reported in the vobarilizumab group.
Dr Robert K.
Zeldin, Chief Medical Officer at Ablynx, said:
"We are disappointed that
vobarilizumab didn't show a dose response in the analysis of the
study's primary endpoint, however, vobarilizumab was well tolerated
in all tested dose groups, confirming its favourable safety
profile. We will continue to analyse the full data set and thank
the study participants and their families as well as the
investigators and staff who contributed to this study."
About the Phase II STEADY
study
This multi-centre, randomised,
double-blind, placebo-controlled, dose-range finding Phase II study
was initiated in August 2015 and enrolled 312 patients with
moderate to severe, active seropositive SLE across the USA, Europe,
South America and Asia. Patients were randomly assigned to one of
four dose groups of subcutaneously (sc) administered vobarilizumab
(75mg every 4 weeks, 150mg every 4 weeks, 150mg every 2 weeks,
225mg every 2 weeks) or placebo. Subjects were evaluated for
efficacy up to and including Week 48 and for safety up to and
including Week 58.
The primary endpoint of the study
was the percentage of subjects who achieved a response at Week 24
according to the modified BICLA (BILAG-based combined lupus
assessment) score. This is a composite measure of SLE disease
activity across all body systems, driven by an improvement in the
BILAG (British Isles Lupus Assessment Group) index, no worsening of
the modified SLEDAI-2K (SLE disease activity index excluding the
low complement scoring) and no significant worsening of the
physician global assessment (PGA), compared to baseline. The
primary endpoint was analysed using the Multiple Comparison
Procedure Model (MCP-Mod) methodology to evaluate the dose-response
relationship. Secondary endpoints included the modified SRI (SLE
responder index), a composite measure of SLE disease activity based
on an improvement in the modified SLEDAI-2K without worsening of
the BILAG index or of the PGA, the individual components of the
composite endpoints, as well as the effects of vobarilizumab on
flare rate, use of corticosteroids and health-related quality of
life.
About SLE
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, neurological and haematological manifestations.
Approximately five million people worldwide suffer from a form of
SLE and 90% of people diagnosed are women.
The management of SLE typically
requires a comprehensive assessment of disease activity, the damage
from the disease, and the careful tailoring of the treatment
according to the involved organs and the disease severity. In
general, treatment aims to manage and control symptoms during the
acute periods of active disease, and to minimise the risk of flares
during periods of remission. Conventional therapies include
anti-malarials, corticosteroids and immunosuppressants and are
often associated with significant risks and adverse effects.
Belimumab, a B-lymphocyte stimulator-specific inhibitor, is the
only approved targeted therapy for the treatment of adult patients
with active autoantibody-positive SLE who are receiving standard
therapy. Overall, there is a substantial unmet medical need for
more effective and better tolerated therapies for the treatment of
SLE.
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). Twenty-four-week data from a Phase I/IIa
proof-of-concept study of ALX-0061 (vobarilizumab) in rheumatoid
arthritis (RA) patients in combination 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
SLE. AbbVie will review the complete data set when available from
the Phase II STEADY SLE study to determine whether to exercise its
option to license vobarilizumab. Should AbbVie exercise the option,
it would trigger a payment to Ablynx. If the option is not
exercised, Ablynx's agreement with AbbVie would terminate.
In July 2016, Ablynx announced
topline results from a 12-week Phase IIb study of vobarilizumab as
a monotherapy in patients with moderate-to-severe RA. The study
demonstrated that vobarilizumab reduced signs and symptoms of RA
and resulted in ACR20, ACR50 and ACR70 scores of up to 81%, 49% and
24% respectively at week 12 as compared to 78%, 45% and 23%,
respectively, at week 12 in the tocilizumab arm. Moreover,
vobarilizumab induced clinical remission based on the disease
activity score (DAS28CRP <2.6) in
up to 41% of patients, as compared to 27% of patients treated with
tocilizumab. Vobarilizumab treatment resulted in improvement in
physical function, and also had a favourable safety profile at all
administered doses.
In August 2016, Ablynx reported
results from a 24-week, double-blind, placebo-controlled Phase IIb
study of vobarilizumab administered as a combination therapy with
methotrexate (MTX) to patients with moderate-to-severe RA. High
ACR20 responses at week 12 were obtained in all treatment groups,
ranging from 62% in the placebo group to between 73% and 81% in the
vobarilizumab treatment groups. ACR20, ACR50 and ACR70 scores at
week 24 were high with respectively 79%, 61% and 45% in the
combined vobarilizumab dosing groups. In addition, vobarilizumab
improved physical function and had a positive impact on disease
activity with up to 70% of patients achieving low disease activity
at week 24 (DAS28CRP less than
or equal to 3.2) and up to 51% of treated patients achieving
clinical remission at week 24 (DAS28CRP
<2.6).
The results of the two Phase II
studies in RA also confirmed the favourable safety profile of
vobarilizumab and the potential for convenient monthly
administration. An open-label extension study in RA patients is
currently ongoing (94% roll-over rate) and results are expected in
H2 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 45 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; Merck & Co., Inc., Kenilworth, New Jersey, USA;
Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The
Company is headquartered in Ghent, Belgium. More information can be
found on www.ablynx.com.
On 29 January 2018, Sanofi made an
offer to acquire all of Ablynx's outstanding ordinary shares
(including shares represented by American Depository Shares (ADSs),
warrants and convertible bonds) at a price of €45 per share, which
represents an aggregate equity value of approximately €3.9 billion.
The proposed transaction was unanimously approved by both the
Sanofi and Ablynx Board of Directors. The tender offer is expected
to be launched in the beginning of the second quarter of 2018.
Sanofi will publish an offer document in which it will set out the
full details of its tender offer, and the Board of Directors of
Ablynx will publish a response memorandum ('memorie van antwoord'),
in which it will set out its position on the tender offer.
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@ablynx.com
Lies Vanneste
Director Investor Relations
t: +32 (0)9 262 01 37
m: +32 (0)498 05 35 79
e: lies.vanneste@ablynx.com
Follow us on Twitter @AblynxABLX
Ablynx media
relations:
Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Sukaina Virji
t: +44 (0)20 3709 5700
e: ablynx@consilium-comms.com
Joele Frank,
Wilkinson Brimmer Katcher
Dan Katcher or Joseph Sala
t: +1 212-355-4449
Disclaimer
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect the Company or, as appropriate, the
Company directors' current expectations and projections about
future events. By their nature, forward-looking statements involve
a number of risks, uncertainties and assumptions that could cause
actual results or events to differ materially from those expressed
or implied by the forward-looking statements. These risks,
uncertainties and assumptions could adversely affect the outcome
and financial effects of the plans and events described herein. A
multitude of factors including, but not limited to, changes in
demand, competition and technology, can cause actual events,
performance or results to differ significantly from any anticipated
development. Forward looking statements contained in this press
release regarding past trends or activities should not be taken as
a representation that such trends or activities will continue in
the future. As a result, the Company expressly disclaims any
obligation or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or
representatives nor any of its parent or subsidiary undertakings or
any such person's officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in
this press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
Additional
Information for US Investors
The tender offer for the outstanding ordinary shares ("Shares"),
American Depositary Shares issued by J.P. Morgan Chase Bank, N.A.,
acting as depositary ("ADSs"), warrants ("Warrants") and
convertible bonds of Ablynx ("Bonds" and, together with the Shares,
ADSs and Warrants, the "Securities") has not yet commenced. This
communication is for informational purposes only and is neither a
recommendation, an offer to purchase nor a solicitation of an offer
to sell any Securities of Ablynx.
At the time the tender offer is
commenced, Sanofi will file, or cause to be filed, a tender offer
statement on Schedule TO with the SEC and thereafter, Ablynx will
file a solicitation/recommendation statement on Schedule 14D-9.
Holders of Securities are urged to carefully review the documents
that will be filed by Sanofi and Ablynx with the SEC because these
documents will contain important information, including the terms
and conditions of the tender offer.
The offer to purchase, the related
letter of transmittal and certain other tender offer documents, as
well as the solicitation/recommendation statement, are available to
all holders of Securities of Ablynx at no expense to them. These
documents are available for free at the SEC's website at
www.sec.gov. Additional copies may be obtained for free by
contacting Sanofi at ir@Sanofi.com or on Sanofi's website at
https://en.Sanofi.com/investors. You should read the filings made
by Sanofi and Ablynx with the SEC carefully before making a
decision concerning the U.S. Offer.
pdf version 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
Ablynx NV (NASDAQ:ABLX)
Historical Stock Chart
From Sep 2024 to Oct 2024
Ablynx NV (NASDAQ:ABLX)
Historical Stock Chart
From Oct 2023 to Oct 2024