- Generally well-tolerated with no clinically relevant safety
signals in Phase 1 study
- At the highest dose level, 5 out of 6 patients (83%) reached
an improvement of at least 50% in atopic dermatitis symptoms
(EASI-50) by week 4
- Results support progression to Phase 2 study
- GLPG's 3rd novel mechanism to show promising patient
results
- MOR106 is the first human monoclonal antibody against IL-17C
in clinical development worldwide
Mechelen, Belgium and Planegg/Munich,
Germany; 27 September 2017; 7.30 CET -Galapagos NV (Euronext
& NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard
Segment, TecDAX; OTC: MPSYY) today announced Phase 1 results with
their joint investigational antibody program MOR106 directed
against IL-17C in patients with moderate-to-severe atopic
dermatitis (AD). MOR106 was generated using MorphoSys's 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 shown to be distinct from other members of the IL-17 cytokine
family. The Phase 1 study was a randomized, double-blind,
placebo-controlled trial, evaluating single ascending doses (SAD)
in healthy volunteers, and multiple ascending doses (MAD) in
patients with moderate-to-severe atopic dermatitis. MOR106 was
administered as an intravenous infusion. The primary objective of
the Phase 1 study was to evaluate the safety and tolerability of
MOR106. The study's secondary objective was to characterize the
pharmacokinetic (PK) profile of MOR106 in patients. Exploratory
objectives to measure early signs of efficacy were also included in
the MAD part of the study. 24 patients, diagnosed with
moderate-to-severe atopic dermatitis, received four weekly
infusions of either placebo or MOR106 in a 1 to 3 ratio of placebo
to MOR106. Patients were followed for 11 weeks after the last
infusion.
Galapagos and MorphoSys previously disclosed
that the SAD "healthy volunteer" part of the Phase 1 study reported
generally favorable safety findings. In the MAD portion in
patients, all adverse drug reactions observed were mild-to-moderate
and transient in nature and did not lead to clinically relevant
safety signals. No serious adverse events (SAEs) and no
infusion-related reactions (IRRs) were recorded. MOR106 reported a
favorable PK profile with dose-dependent exposure and a half-life
in patients in line with what was observed in healthy
volunteers.
Even though the study was not statistically
powered to show differences in efficacy between treatment groups,
at the highest dose level of MOR106, in 83% of patients (5 out of
6) an improvement of at least 50% in signs and symptoms of atopic
dermatitis measured by the Eczema Area and Severity Index (EASI-50)
was recorded at week 4. The onset of activity was rapid and
occurred within few weeks and was maintained for over 2 months
after the last treatment. Among patients receiving placebo, in 17%
of patients (1 out of 6) an EASI-50 improvement was seen at week
4.
"Moderate-to-severe atopic dermatitis is a
chronic, debilitating disease affecting millions of patients
worldwide with a clear unmet medical need for safe and efficacious
treatments. In this Phase 1 study MOR106 was observed to be
generally well-tolerated, with a favorable PK profile. In
addition, we have seen first very promising signs of clinical
activity, with a response sustained for months after stopping
treatment," said Professor Diamant Thaçi MD, Direktor Institut für
Entzündungsmedizin Universitätsklinikum Schleswig-Holstein Campus
Lübeck and Independent Advisor for the study. "There is plenty of
room in the clinicians' armamentarium for new treatments in this
field, so I very much look forward to working further on the
evaluation of this investigational compound and its potential role
in treating atopic dermatitis."
"Following JAK1 and autotaxin, IL-17C is the
third mechanism out of our proprietary target discovery platform
for which we are excited to pursue clinical development,
underlining extracellular mechanisms of action as a new area of
development for us," said Dr. Piet Wigerinck, CSO of Galapagos. "We
are very pleased with the outcome of this initial patient study
with the first novel mechanism antibody directed against IL-17C in
the Galapagos pipeline. The Phase 1 results of MOR106 support its
progression into Phase 2 development in patients. In parallel, we
will evaluate the switch to subcutaneous administration."
"We are delighted with these first Phase 1
clinical results from our joint antibody program with Galapagos in
patients with moderate-to-severe atopic dermatitis. MOR106 is
MorphoSys's fifth program in Morphosys' proprietary development
portfolio and the first antibody from our Ylanthia technology
platform in the clinic. These data further encourage us to develop
MOR106 as a potential novel biologic therapy for patients suffering
from this severe disease with high medical need together with our
partner Galapagos", commented Dr. Malte Peters, Chief Development
Officer of MorphoSys AG.
Galapagos and MorphoSys intend to present the
clinical data from this study with MOR106 at a future medical
conference.
About Atopic DermatitisAtopic dermatitis, also known as
atopic eczema, is a chronic pruritic (itching) inflammatory skin
disease that most frequently starts in early childhood, often
persists into adulthood, but may also have an adult onset.
According to GlobalData, there were 35 million atopic dermatitis
patients in the US, the major EU nations and Japan in 2016,
approximately 25 million of which were estimated to be
moderate-to-severe cases. The main features of atopic dermatitis
are the impairment of the skin barrier and dysfunction of the
immune system accompanied with dry skin and severe pruritus that is
associated with cutaneous hyperactivity to various environmental
stimuli. The pruritus (itching) may lead to sleep loss, anxiety,
depression and impaired social life and is therefore considered as
highest therapeutic need in atopic dermatitis.
About IL-17CIL-17C is a cytokine that is
broadly expressed in human skin pathologies and is a checkpoint in
innate skin immunology, 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
collaborationMOR106 is an investigational 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 provides the disease-related biology including
cellular assays and targets discovered using its target discovery
platform. MorphoSys contributes its Ylanthia antibody technology to
generate fully human antibodies directed against the target and
contributes full CMC development of this compound. Galapagos and
MorphoSys will continue to co-develop MOR106 further in the
clinic.
About MorphoSysMorphoSys's mission is to
make exceptional, innovative biopharmaceuticals to improve the
lives of patients suffering from serious diseases. Innovative
technologies and smart development strategies are central to our
approach. Success is created by our people, who focus on excellence
in all they do, collaborate closely across disciplines and are
driven by a desire to make the medicines of tomorrow a reality.
Success benefits all of our stakeholders. Based on its proprietary
technology platforms, particularly in the field of fully human
therapeutic antibodies, MorphoSys, together with its partners, has
built a therapeutic pipeline of more than 110 programs in R&D,
around a quarter of which is currently in clinical development. In
its proprietary development segment, MorphoSys, alone or with
partners, is developing new therapeutic candidates, mainly focusing
on cancer and inflammation. In its partnered discovery segment,
MorphoSys uses its technologies to discover new drug candidates for
pharmaceutical partners and participates from the programs' further
development success, through success-based payments and royalties.
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 GalapagosGalapagos (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. Galapagos has demonstrated proof of platform
with filgotinib targeting JAK1 in inflammatory conditions
(collaboration with Gilead), GLPG1690 targeting autotaxin in IPF,
and MOR106 targeting IL-17C in atopic dermatitis (collaboration
with MorphoSys). 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 550 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands,
France, and Croatia. More information at www.glpg.com.
ContactMorphoSys AGAnke Linnartz, Head of
Corporate Communications & IR Jochen Orlowski, Associate
Director Corporate Communications & IRAlexandra Goller, Senior
Manager Corporate Communications & IRTel: +49 (0) 89 / 899
27-404investors@morphosys.com
GalapagosInvestors:Elizabeth GoodwinVP IR &
Corporate Communications +1 781 460 1784
Paul van der HorstDirector IR & Business Development +31 71
750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Galapagos forward-looking statementsThis
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.
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