01.05.2018
MorphoSys AG DE0006632003
DGAP-News: MorphoSys and Galapagos Announce Initiation of the IGUANA Phase 2 Clinical Trial With MOR106 in Atopic Dermatitis Patients
DGAP-News: MorphoSys AG / Key word(s): Study
MorphoSys and Galapagos Announce Initiation of the IGUANA Phase 2 Clinical
Trial With MOR106 in Atopic Dermatitis Patients (news with additional
features)
01.05.2018 / 22:00
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany and Mechelen, Belgium; May 1, 2018
MorphoSys and Galapagos Announce Initiation of the IGUANA Phase 2 Clinical
Trial With MOR106 in Atopic Dermatitis Patients
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR; OTC:
MPSYY) and Galapagos NV (Euronext & NASDAQ: GLPG) announced today that the
first patient has been enrolled in IGUANA, a phase 2 study with MOR106, an
investigational antibody directed against IL-17C, in atopic dermatitis
patients.
IGUANA - A MOR106 phase 2 trial
At least 180 patients with moderate-to-severe atopic dermatitis (AD) are
planned be treated over a 12-week period with one of three different doses
of MOR106 (1, 3 or 10 mg/kg) or placebo using two different dosing regimens
in this phase 2 trial in multiple centers across Europe. The placebo
controlled, double-blind study will evaluate the efficacy, safety and
pharmacokinetics (PK) of MOR106. Dosing at 2 or 4-week intervals will be
evaluated over the 12-week treatment period, followed by a 16-week
observation period. The primary objective will be assessed by the percentage
change from baseline in Eczema Area and Severity Index (EASI) score at week
12.
"Moderate-to-severe AD is a chronic, debilitating disease affecting millions
of patients worldwide," said Dr. Malte Peters, Chief Development Officer of
MorphoSys AG. "We see a clear unmet medical need for additional safe and
efficacious treatment options and we are looking forward to further
developing MOR106 for these patients in the phase 2 trial we have now
initiated together with our partner Galapagos."
"The IGUANA trial is aimed at providing a robustly supported data set on
MOR106 in atopic dermatitis patients. We look forward to seeing what this
IL-17C mechanism of action can bring to a larger trial population for longer
treatment duration," said Dr. Piet Wigerinck, Chief Scientific Officer of
Galapagos.
MOR106 was generated using MorphoSys's Ylanthia antibody platform and is
based on a target discovered by Galapagos. IL-17C is a cytokine expressed
preferentially in the skin and which has been implicated in dermal
inflammation and shown to be distinct from other members of the IL-17
cytokine family. MOR106 is the first publicly known human monoclonal
antibody directed against IL-17C in clinical development worldwide. MOR106
is an investigational drug and its safety and efficacy are yet to be
established.
About MOR106 results of a phase 1 study in atopic dermatitis (AD)
Clinical data of a MOR106 Phase 1 trial in AD patients were presented at the
American Academy of Dermatology (AAD) conference in February 2018 in San
Diego. After 4 infusions in weekly intervals, MOR106 showed preliminary
signs of efficacy (5 out of 6 patients responded at the highest dose) and
was generally well tolerated (Thaçi et al., 2018, AAD).
About atopic dermatitis
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 affected 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 AD 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 AD 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 of Galapagos and MorphoSys
MOR106 is an investigational fully human IgG1 monoclonal antibody designed
to selectively target IL-17C, currently being developed for treatment of
inflammatory diseases. 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 equally share research and development costs, as
well as all future economics.
About MorphoSys
MorphoSys is a late-stage, biopharmaceutical company devoted to the
development of innovative and differentiated therapies for patients
suffering from serious diseases. Based on its technological leadership in
generating antibodies, MorphoSys, together with its partners, has developed
and contributed to the development of more than 100 product candidates, of
which 28 are currently in clinical development. This broad pipeline spans
MorphoSys's two business segments: Proprietary Development, in which
MorphoSys invests in product candidates for its own account, and Partnered
Discovery, in which product candidates are developed exclusively for a
variety of Pharma and Biotech partners. In 2017, Tremfya(R) (guselkumab),
marketed by Janssen, became the first therapeutic antibody based on
MorphoSys's proprietary technology to receive marketing approval for the
treatment of moderate-to-severe plaque psoriasis in the United States, the
European Union and Canada. MorphoSys is listed on the Frankfurt Stock
Exchange and on the U.S. stock exchange Nasdaq, under the symbol MOR. For
regular updates about MorphoSys, visit http://www.morphosys.com.
HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R),
arYla(R),
Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R)
and LanthioPep(R) are registered trademarks of the MorphoSys Group.
Tremfya(R)
is a trademark of Janssen Biotech, Inc.
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.
MorphoSys forward looking statements
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the commencement of the IGUANA
trial in connection with MOR106 and expectations regarding the development
of MOR106 in moderate-to-severe atopic dermatitis, including the intended
targeting of IL-17C. The forward-looking statements contained herein
represent the judgment of MorphoSys as of the date of this release and
involve known and unknown risks and uncertainties, which might cause the
actual results, financial condition and liquidity, performance or
achievements of MorphoSys, 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 MorphoSys' 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, MorphoSys'
reliance on collaborations with third parties and other risks indicated in
the risk factors included in MorphoSys's Registration Statement on Form F-1
and other filings with the US Securities and Exchange Commission. 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. MorphoSys 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 Alexandra Goller Galapagos NV Investors: Elizabeth
Associate Director Corporate Goodwin VP IR & Corporate
Communications & IR Jochen Communications +1 781 460 1784
Orlowski Associate Director Paul van der Horst Director IR &
Corporate Communications & IR Dr. Business Development +31 71 750
Claudia Gutjahr-Löser Investor 6707 [email protected] Media: Evelyn Fox
Relations Officer Tel: +49 (0) 89 Director Communications +31 6 53
/ 899 27-404 591 999 [email protected]
[email protected]
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Additional features:
Document: http://n.eqs.com/c/fncls.ssp?u=MEQGQYAPUG
Document title: Media Release
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01.05.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: [email protected]
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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