-
MOR106 was generally well
tolerated in atopic dermatitis (AD) patients
-
83% of patients (5 out of 6) at
the highest dose reached at least 50% improvement per the atopic
dermatitis area and severity index (EASI-50) at week 4
-
Pooled data across dose cohorts
showed 72% improvement of AD symptoms at week 12 compared to
baseline in patients treated with MOR106
-
Phase 2 development of MOR106
planned to be initiated in first half of 2018
Mechelen, Belgium
and Planegg/Munich, Germany; 17 February 2018; 10.00
CET -Galapagos NV (Euronext & NASDAQ: GLPG) and MorphoSys
AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced
the presentation of more detailed results of the Phase 1 study with
the investigational IL-17C antibody MOR106 in AD patients at the
American Academy of Dermatology (AAD) Annual Meeting 2018 in San
Diego, CA, USA, held from 16-20 February. Initial study data were
reported in September 2017. In the study, MOR106 showed first signs
of activity and durable responses and was generally well tolerated
in AD patients.
Professor Diamant Thaçi MD,
Director of the Institute for Inflammation Medicine at the
University Clinic Schleswig-Holstein Campus Luebeck and Independent
Advisor for the study, presented results of the randomized,
double-blind, placebo-controlled Phase 1 trial, evaluating single
ascending doses (SAD) of MOR106 in healthy volunteers, and multiple
ascending doses (MAD) in patients with moderate-to-severe AD in the
late breaking abstracts session at AAD 2018. In the MAD part, 25
patients received four infusions once weekly of either MOR106 (at
the doses of 1, 3, and 10 mg/kg body weight, respectively) or
placebo in a 3:1 ratio. Patients were followed for 10 weeks after
the end of the treatment period.
"Moderate-to-severe AD is a
chronic, debilitating disease affecting millions of patients
worldwide with a clear unmet medical need for safe and efficacious
treatments," said Professor Diamant Thaçi MD. "Both the first signs
of clinical activity and the sustained response lasting up to two
months after treatment discontinuation support further clinical
development of MOR106."
In the MAD part in AD patients
reported at AAD 2018, all adverse drug reactions observed were
mild-to-moderate and transient in nature. No serious adverse events
(SAEs) and no infusion-related reactions were recorded. MOR106
exhibited a favorable pharmacokinetics profile with dose-dependent
exposure.
At the highest dose level of
MOR106 (10mg/kg body weight), in 83% of patients (5 out of 6) an
improvement of at least 50% in signs and extent of AD, as measured
by EASI-50, was recorded at week 4. The onset of activity occurred
within two to four weeks, depending on the dose administered.
Pooled data across dose cohorts
showed that patients treated with MOR106 achieved an EASI
improvement compared to baseline of 58%, 62%, 72%, and 64% at week
4, 8, 12, and 14, respectively. For patients receiving placebo, the
EASI improvement was 32%, 40%, 38%, and 50%.
MOR106 was generated using
MorphoSys' Ylanthia antibody platform and is based on a target
discovered by Galapagos. IL-17C is a cytokine which has been
related to dermal inflammation and has been shown to be distinct
from other members of the IL-17 cytokine family. MOR106 is the
first publically known human monoclonal antibody against IL-17C in
clinical development worldwide. MOR106 is an investigational drug
and its safety and efficacy are yet to be established.
It is expected that Phase 2
development with MOR106 will be initiated in the first half of
2018.
Details of the
oral presentation on MOR106 at AAD 2018:
Abstract #6753 - MOR106, an Anti-IL-17C mAb, a Potential New
Approach for Treatment of Moderate-to-severe Atopic Dermatitis:
Phase 1 Study.
Session #F061 - Late-breaking Research: Clinical Trials
Date: Saturday, February 17 from 1:00 PM - 3:00 PM PT (10:00 PM -
0:00 AM CET)
Place: Ballroom 20A
Presenter: Professor Diamant Thaçi MD, Director of the Institute
for Inflammation Medicine at the University Clinic
Schleswig-Holstein Campus Luebeck
About AD
Atopic dermatitis (AD), the most severe and common type of eczema,
is a chronic relapsing inflammatory skin disease that causes severe
itch, dry skin and rashes, predominantly on the face, inner side of
the elbows and knees, and on hands and feet. Scratching of the
afflicted skin leads to a vicious cycle causing redness, swelling,
cracking, scaling of the skin and an increased risk of bacterial
infections. Lichenification, thickening of the skin, is
characteristic in older children and adults. The National Eczema
Association estimates that atopic dermatitis affects over 30
million Americans or up to 25% of children and 2-3% of adults. 60%
of AD patients are diagnosed in the first year of life, and 90% of
patients have a disease onset before age five. Symptoms commonly
fade during childhood, however, approximately 10-30% of the
patients will suffer from atopic dermatitis for life. A smaller
percentage first develop symptoms as adults.
About
IL-17C
IL-17C is a cytokine that is broadly expressed in human skin
pathologies and is described as an important modulator of the
innate immune system of the skin, distinct from other members of
the IL-17 cytokine family. IL-17C plays a crucial role in human
inflammatory conditions, including skin diseases.
About MOR106 and
the antibody collaboration
MOR106 is an investigational fully human IgG1 monoclonal antibody
currently being developed for treatment of inflammatory diseases.
It is the first publicly disclosed human monoclonal antibody
designed to selectively target IL-17C in clinical development
worldwide. MOR106 arises from the strategic discovery and
co-development alliance between Galapagos and MorphoSys, in which
both companies contribute their core technologies and expertise.
Galapagos has provided the disease-related biology including
cellular assays and targets discovered using its target discovery
platform. MorphoSys has contributed its Ylanthia antibody
technology to generate fully human antibodies directed against the
target and contributes full CMC development of this compound.
Galapagos and MorphoSys share research and development costs
equally, as well as all future economics.
About
MorphoSys
MorphoSys a late-stage biopharmaceutical company devoted to the
development of innovative and differentiated therapies for patients
suffering from serious diseases. Based on our proprietary
technology platforms and leadership in the field of therapeutic
antibodies, we, together with our partners, have participated in
the development of more than 100 therapeutic product candidates
currently in R&D, 28 of which in clinical development. Our
broad pipeline spans two business segments: Proprietary
Development, in which we invest in and develop product candidates,
and Partnered Discovery, in which we generate product candidates
for our partners in the pharmaceutical and biotechnology industries
against targets identified by our partners. MorphoSys is listed on
the Frankfurt Stock Exchange under the symbol MOR. For regular
updates about MorphoSys, visit http://www.morphosys.com.
HuCAL®, HuCAL GOLD®, HuCAL
PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion
high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are
registered trademarks of the MorphoSys Group.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage
biotechnology company specialized in the discovery and development
of small molecule medicines with novel modes of action. Galapagos'
pipeline comprises Phase 3 through to discovery programs in cystic
fibrosis, inflammation, fibrosis, osteoarthritis and other
indications. Our target discovery platform has delivered three
novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic pulmonary fibrosis
and atopic dermatitis. Galapagos is focused on the development and
commercialization of novel medicines that will improve people's
lives. The Galapagos group, including fee-for-service subsidiary
Fidelta, has approximately 600 employees, operating from its
Mechelen, Belgium headquarters and facilities in the Netherlands,
France, Switzerland, the US and Croatia. More information at
www.glpg.com.
Contact
MorphoSys AG
Anke Linnartz, Head of Corporate Communications & IR
Jochen Orlowski, Associate Director Corporate Communications &
IR
Alexandra Goller, Associate Director Corporate Communications &
IR
Tel: +49 (0) 89 / 899 27-404
investors@morphosys.com
Galapagos
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir@glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Galapagos
forward-looking statements
This release may contain forward-looking
statements pertaining to Galapagos, including, among other things,
statements regarding the mechanism of action and safety and
efficacy profile of MOR106, or regarding the timing, progress
and/or results of clinical studies with MOR106. Galapagos cautions
the reader that forward-looking statements are not guarantees of
future performance. Forward-looking statements involve known and
unknown risks, uncertainties and other factors which might cause
the actual results, financial condition and liquidity, performance
or achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos'
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are that Galapagos' expectations
regarding its MOR106 development program may be incorrect, the
inherent uncertainties associated with competitive developments,
clinical trial and product development activities and regulatory
approval requirements (including that data from Galapagos' ongoing
clinical research program may not support registration or further
development of MOR106 due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties (including
its collaboration partner for MOR106, MorphoSys), and estimating
the commercial potential of MOR106. A further list and description
of these risks, uncertainties and other risks can be found in
Galapagos' Securities and Exchange Commission (SEC) filings and
reports, including in Galapagos' most recent annual report on form
20-F filed with the SEC and other filings and reports filed by
Galapagos with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. Galapagos expressly disclaims
any obligation to update any such forward-looking statements in
this document to reflect any change in its expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statement is based or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements, unless specifically required by law or
regulation.
Ph1 MOR106 at AAD
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: Galapagos NV via Globenewswire
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