- 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; 29 September 2016 - 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
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
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Apr 2024 to May 2024
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From May 2023 to May 2024