ABLYNX'S PARTNER, MERCK KGaA, HAS PRESENTED NEW DATA FROM A PHASE Ib PSORIASIS STUDY OF THE BI-SPECIFIC ANTI-IL-17A/F NANOBODY AT THE ANNUAL AAD CONFERENCE
(Thomson Reuters ONE) -
* All patients in the highest dose group achieved 90% skin clearance (PASI
90) compared to 0% for placebo
* Skin biopsy showed complete reversal of disease pathology in the majority of
patients in the high dose group
* The onset of clinical effect was rapid and sustained throughout the study
* Favourable safety and tolerability profile across all doses tested
GHENT, Belgium, 6 March 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY]
today announced that its partner, Merck KGaA (Darmstadt, Germany), has presented
new data from a Phase Ib study demonstrating strong efficacy with the bi-
specific anti-IL-17A/F Nanobody® (M1095; ALX-0761) in patients with moderate-to-
severe chronic plaque psoriasis. The results were presented at the 75(th) Annual
Meeting of the American Academy of Dermatology Conference, taking place from
3-7 March 2017, in Orlando, Florida.
The Phase Ib study was a multi-centre, double-blind, randomised, placebo-
controlled trial in 41 patients with moderate-to-severe chronic plaque psoriasis
to evaluate the safety, tolerability and immunogenicity of multiple ascending
doses of M1095, ranging from 30mg to 240mg administered subcutaneously on days
1, 15 and 29. The study also evaluated pharmacokinetic profiles and efficacy of
multiple subcutaneous doses of M1095.
A reduction in disease activity, as measured by the Psoriasis Area Severity
Index (PASI) and improvement in static Physician Global Assessment (sPGA) was
seen for all doses of M1095 versus 0% for placebo. At day 85, all patients
treated with 240mg M1095 experienced a 75% reduction in disease activity (PASI
75) and had clear or almost clear skin (PASI 90); moreover, 56% of patients in
this highest dose group had clear skin (PASI 100). In addition, rapid onset of
clinical effect was observed after the first administered dose and sustained
through to completion of the study at day 85.
M1095 had a favourable safety and tolerability profile, with no treatment-
related serious adverse events reported and no dose-dependent increase in
frequency or severity of adverse events. There was no apparent effect of anti-
drug antibodies on pharmacokinetics.
The presentation 'Safety and efficacy of multiple ascending doses of
subcutaneous M1095, an anti-interleukin-17A/F bi-specific Nanobody®, in patients
with moderate-to-severe psoriasis' is available on the Ablynx website under R&D
portfolio.
Dr Edwin Moses, CEO of Ablynx, commented: "This Nanobody was developed as part
of a deal we signed with Merck KGaA in 2008 and was the first functional bi-
specific Nanobody to reach the clinic. We were responsible for the discovery and
some of the pre-clinical work and Merck KGaA is now responsible for the clinical
development and commercialisation of this drug candidate. These initial clinical
data are very encouraging compared to other psoriasis therapeutics commercially
available, and in development. We believe that the results are a further
validation of the enormous potential of the Nanobody platform to generate
differentiating multi-specific drug candidates for the treatment of a wide range
of diseases."
About M1095 (anti-IL-17A/F)
The interleukin (IL)-17A/F bispecific Nanobody neutralizes the pro-inflammatory
cytokines IL-17A and IL-17F, which are each expressed at inflammatory sites, and
have both been implicated in the pathogenesis of psoriasis and several auto-
immune disorders. The interleukin-17 (IL-17) family of cytokines includes six
IL-17-family ligands, and five receptors. IL-17A is the most studied family
member and most often mentioned as IL-17. IL-17F is the closest relative to IL-
17A based on sequence and receptor binding. Indeed, while both IL-17A and IL-
17F exist as homodimers, an IL-17A/F heterodimer has also been described. In
addition, both IL-17F and IL-17A bind the IL-17RA and IL-17RC receptors. A
difference between IL-17A and IL-17F is that their expression may be
differentially regulated at both the cell-type and transcriptional levels
accounting for non-redundant roles in vivo. IL-17A and IL-17F are important
mediators of local and systemic inflammation. Their activities are often
additive or synergistic to that of other inflammatory mediators such as tumour
necrosis factor (TNF). This described biology of IL-17A and IL-17F supports a
role for both cytokines in the initiation and perpetuation of Th17-associated
chronic auto-immune and inflammatory diseases and in subsequent organ damage.
The bi-specific anti-IL-17A/F Nanobody (M1095) was discovered by Ablynx. Merck
KGaA is now responsible for the clinical development and commercialisation of
M1095 with Ablynx set to potentially receive milestones and royalties as the
programme progresses.
About the Psoriasis Area Severity Index (PASI)
Psoriasis Area and Severity Index (PASI) is the most widely used tool for the
measurement of severity of psoriasis. It assesses treatment efficacy by
measuring the reduction in redness, scaling and thickness of psoriatic plaques
and the extent of involvement in each region of the body. PASI combines the
assessment of the severity of lesions and the area affected into a single score.
PASI is widely used in clinical trials of therapies to treat psoriasis. Although
absolute PASI score is often used to define entry into a trial, it is response
to treatment that is important to measure efficacy and outcomes. This is usually
presented as a percentage response rate; e.g. PASI 50, PASI 75, PASI 90, PASI
100. PASI 75, for example, represents the percentage (or number) of patients who
have achieved a 75% or more reduction in their PASI score from baseline. PASI
100 indicates patients who have achieved a complete resolution of all disease.
About static Physician Global Assessment (sPGA)
A key measure used in clinical trials of psoriasis is the physician global
assessment (PGA). Global assessments can be done for extensive disease as well
as localized plaques. The static PGA measures the physician's impression of the
disease at a single point. The static Physician's Global Assessment (sPGA) scale
rates the investigator's overall clinical assessment of a subjects plaque
thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear,
except for residual discoloration) to 5 (majority of plaques have severe
thickness, erythema, and scale). To assign a sPGA score, the investigator
examines all psoriatic lesions and assigns a severity score ranging from 0 to 5
for thickness, erythema, and scaling. Scores for thickness, erythema, and
scaling are summed and the mean of these 3 scores equals the overall sPGA score.
Overall sPGA scores range from 0 to 5, where lower scores indicate clinical
improvement. In this study, the percentage of subjects who achieved a sPGA
rating of 0 (clear) or 1 (minimal) and had at least a 2 level reduction from
baseline score were reported.
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., 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
pdf format of the press release:
http://hugin.info/137912/R/2084916/786067.pdf
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
Unternehmensinformation / Kurzprofil:
Datum: 06.03.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 528174
Anzahl Zeichen: 9959
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 220 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"ABLYNX'S PARTNER, MERCK KGaA, HAS PRESENTED NEW DATA FROM A PHASE Ib PSORIASIS STUDY OF THE BI-SPECIFIC ANTI-IL-17A/F NANOBODY AT THE ANNUAL AAD CONFERENCE"
steht unter der journalistisch-redaktionellen Verantwortung von
Ablynx (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
