- Ongoing Phase 1 study in healthy volunteers now advanced to
investigate MOR106 in patients with atopic dermatitis
- Favorable safety results shown in healthy volunteers
receiving single ascending doses (SAD) in the study to
date
- MOR106 first publicly disclosed antibody targeting IL-17C in
clinical studies worldwide
MECHELEN, Belgium and MARTINSRIED/MUNICH,
Germany, Sept. 29, 2016 (GLOBE NEWSWIRE) -- Galapagos NV
(Euronext & NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime
Standard Segment, TecDAX; OTC: MPSYY) announced today that the
first patient with atopic dermatitis was dosed in an ongoing
clinical phase 1 study with their jointly discovered and developed
human monoclonal antibody MOR106 against IL-17C.
"Progression of MOR106 into clinical testing in
patients suffering from atopic dermatitis is an important step
forward in the development of this novel antibody. We look forward
to finding out how this translates into safety and pharmacokinetics
in patients," says Dr. Piet Wigerinck, Chief Scientific Officer of
Galapagos.
"We are delighted that MOR106 is now being
investigated in patients after favorable safety results were shown
in healthy volunteers. We see a high unmet medical need for novel
antibody therapies in inflammatory skin disorders such as atopic
dermatitis. MOR106 is designed to selectively target and inhibit
IL-17C, a cytokine related to dermal inflammation," commented Dr.
Arndt Schottelius, Chief Development Officer of MorphoSys AG.
MOR106 is the first publicly disclosed
monoclonal antibody targeting IL-17C in clinical development
worldwide. IL-17C has been shown to be distinct from other members
of the IL-17 cytokine family and to play an important and
pro-inflammatory role in certain skin disorders.
The primary objective of the ongoing randomized,
double-blind, placebo-controlled Phase 1 study is to evaluate the
safety and tolerability. As secondary endpoints, the study will
assess pharmacokinetics and potential immunogenicity of MOR106.
The first part of the study is being conducted
as a single center study in 56 healthy volunteers, evaluating
single ascending doses (SAD) as intravenous infusion compared to
placebo. To date, MOR106 has shown favorable safety and PK results
administered to healthy volunteers in the ongoing study. This has
triggered the start of the second part of the study investigating
multiple ascending doses (MAD) compared to placebo in approximately
24 patients with moderate to severe atopic dermatitis in several
European study centers. As previously reported, topline results of
the complete study, including the MAD part in patients and further
results from the SAD part in healthy volunteers, are expected for
the second half of 2017.
About IL-17C IL-17C has been shown to be
distinct from other members of the IL-17 cytokine family. In
inflammatory skin disorders, IL-17C has been identified as an
important pro-inflammatory mediator.
About MOR106 and the collaboration in the
field of antibodies MOR106 is the first publicly disclosed
human monoclonal antibody designed to selectively target IL-17C in
clinical development worldwide. It has been shown to potently
inhibit the binding of IL-17C to its receptor and thus to inhibit
its biological activity. Results in rodent inflammatory skin models
of atopic dermatitis and psoriasis supports clinical development of
MOR106.
MOR106 arises from a 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 Atopic Dermatitis Atopic
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 (2015), there were 29.1
million moderate-affected and 16.4 million severe-affected patients
out of total 66.3 million atopic dermatitis patients in the 9 major
markets (US, Germany, UK, France, Italy, Spain, Japan, China,
India) in 2014. 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 MorphoSys MorphoSys developed
HuCAL, the most successful antibody library technology in the
pharmaceutical industry. By successfully applying this and other
patented technologies, MorphoSys has become a leader in the field
of therapeutic antibodies, one of the fastest-growing drug classes
in human healthcare. Together with its pharmaceutical partners,
MorphoSys has built a therapeutic pipeline of more than 100 human
antibody drug candidates for the treatment of cancer, rheumatoid
arthritis, and Alzheimer's disease, to name just a few. With its
ongoing commitment to new antibody technology and drug development,
MorphoSys is focused on making the healthcare products of tomorrow.
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. Our pipeline comprises Phase 3, 2, 1,
pre-clinical, and discovery programs in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications. We
have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world. 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 460
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
MorphoSys forward looking statements This
communication contains certain forward-looking statements
concerning the MorphoSys group of companies. The forward-looking
statements contained herein represent the judgment of MorphoSys as
of the date of this release and involve risks and uncertainties.
Should actual conditions differ from the Company's assumptions,
actual results and actions may differ from those anticipated.
MorphoSys does not intend to update any of these forward-looking
statements as far as the wording of the relevant press release is
concerned.
Galapagos forward looking statements This
release may contain forward-looking statements, including
statements regarding the anticipated timing of clinical studies
with MOR106, the progression and results of such studies, the
potential activity, safety profile and clinical efficacy of 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 the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities and regulatory approval requirements
(including that data from the ongoing clinical trial with MOR106
may not support registration or further development of MOR106 due
to safety, efficacy or other reasons), estimating the commercial
potential of MOR106 and Galapagos' reliance on collaborations with
third parties (including its collaboration partner for MOR106,
MorphoSys). 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 20-F filing and subsequent 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.
For more information, please contact:
MorphoSys AG |
Galapagos NV |
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR Jochen Orlowski Associate
Director Corporate Communications & IR Alexandra Goller Senior
Manager Corporate Communications & IR Tel: +49 (0) 89 / 899
27-404 investors@morphosys.com |
Investors: Elizabeth
Goodwin VP IR & Corporate Communications Tel: +1 781 460 1784
ir@glpg.com Media: Evelyn Fox Director Communications Tel: +31 6 53
591 999 communications@glpg.com |
MorphoSys and GLPG start FiP dosing of MOR106 in atopic
dermatitis http://hugin.info/133350/R/2045389/764052.pdf
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