Mechelen, Belgium and Planegg/Munich,
Germany; 1 May 2018; 22.01 CET - Galapagos NV (Euronext &
NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard Segment,
TecDAX; OTC: MPSYY) announced today that the first patient has been
screened in IGUANA, a Phase 2 study with MOR106, an investigational
antibody directed against IL-17C, in atopic dermatitis
patients.
IGUANA - A MOR106 Phase 2 trialAt least
180 patients with moderate-to-severe atopic dermatitis (AD) are
planned to 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 robust
dataset 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' 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 have not yet been
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, an improvement of at least 50% in
the Eczema Area and Severity Index (EASI-50) was observed in 83% of
patients (5 out of 6) at week 4 at the highest dose level of
MOR106. The onset of activity occurred within two to four weeks,
depending on the dose administered. Pooled data across all dose
cohorts showed that AD patients treated with MOR106 achieved an
EASI improvement compared to baseline of 58%, 62%, 72%, and 64% at
week 4, 8, 12, and 14, respectively. For patients receiving
placebo, the EASI improvement was 32%, 40%, 38%, and 50%. MOR106
was generally well tolerated in this trial. Any adverse drug
reactions observed in relation to MOR106 were mild-to-moderate and
transient in nature. No serious adverse events or infusion-related
reactions were recorded (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-17CIL-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 MorphoSysMOR106 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 MorphoSysMorphoSys 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® (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 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. Tremfya® 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 634
employees, operating from its Mechelen, Belgium headquarters and
facilities in the Netherlands, France, Switzerland, the US and
Croatia. More information at www.glpg.com.
ContactMorphoSys AGAlexandra Goller, Associate
Director Corporate Communications & IRJochen Orlowski,
Associate Director Corporate Communications & IRDr. Claudia
Gutjahr-Loeser, Investor Relations Officer Tel: +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
Galapagos' strategic ambitions, the mechanism of action and
potential safety and efficacy of MOR106, or regarding the timing,
progress and/or results of clinical trials with MOR106, and the
potential commercialization of MOR106, if approved. 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 and
planned 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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