MorphoSys and Galapagos Start First-In-Patient Dosing of IL-17C Antibody MOR106 in Atopic Dermatitis
(Thomson Reuters ONE) -
* 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 Investors:
Head of Corporate Communications & IR Elizabeth Goodwin
VP IR & Corporate Communications
Jochen Orlowski Tel: +1 781 460 1784
Associate Director Corporate Communications & ir(at)glpg.com
IR
Media:
Alexandra Goller Evelyn Fox
Senior Manager Corporate Communications & IR Director Communications
Tel: +31 6 53 591 999
Tel: +49 (0) 89 / 899 27-404 communications(at)glpg.com
investors(at)morphosys.com
MorphoSys and GLPG start FiP dosing of MOR106 in atopic dermatitis:
http://hugin.info/133350/R/2045389/764052.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: Galapagos NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 29.09.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 497744
Anzahl Zeichen: 12816
contact information:
Town:
Mechelen
Kategorie:
Business News
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