- MOR106 was generally well tolerated in atopic dermatitis
(AD) patients
- 83% of patients (5 out of 6) at the highest dose reached at
least 50% improvement per the atopic dermatitis area and severity
index (EASI-50) at week 4
- Pooled data across dose cohorts showed 72% improvement of AD
symptoms at week 12 compared to baseline in patients treated with
MOR106
- Phase 2 development of MOR106 planned to be initiated in
first half of 2018
Mechelen, Belgium and Planegg/Munich,
Germany; 17 February 2018; 10.00 CET -Galapagos NV (Euronext
& NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard
Segment, TecDAX; OTC: MPSYY) announced the presentation of more
detailed results of the Phase 1 study with the investigational
IL-17C antibody MOR106 in AD patients at the American Academy of
Dermatology (AAD) Annual Meeting 2018 in San Diego, CA, USA, held
from 16-20 February. Initial study data were reported in September
2017. In the study, MOR106 showed first signs of activity and
durable responses and was generally well tolerated in AD
patients.
Professor Diamant Thaçi MD, Director of the
Institute for Inflammation Medicine at the University Clinic
Schleswig-Holstein Campus Luebeck and Independent Advisor for the
study, presented results of the randomized, double-blind,
placebo-controlled Phase 1 trial, evaluating single ascending doses
(SAD) of MOR106 in healthy volunteers, and multiple ascending doses
(MAD) in patients with moderate-to-severe AD in the late breaking
abstracts session at AAD 2018. In the MAD part, 25 patients
received four infusions once weekly of either MOR106 (at the doses
of 1, 3, and 10 mg/kg body weight, respectively) or placebo in a
3:1 ratio. Patients were followed for 10 weeks after the end of the
treatment period.
"Moderate-to-severe AD is a chronic,
debilitating disease affecting millions of patients worldwide with
a clear unmet medical need for safe and efficacious treatments,"
said Professor Diamant Thaçi MD. "Both the first signs of clinical
activity and the sustained response lasting up to two months after
treatment discontinuation support further clinical development of
MOR106."
In the MAD part in AD patients reported at AAD
2018, all adverse drug reactions observed were mild-to-moderate and
transient in nature. No serious adverse events (SAEs) and no
infusion-related reactions were recorded. MOR106 exhibited a
favorable pharmacokinetics profile with dose-dependent
exposure.
At the highest dose level of MOR106 (10mg/kg
body weight), in 83% of patients (5 out of 6) an improvement of at
least 50% in signs and extent of AD, as measured by EASI-50, was
recorded at week 4. The onset of activity occurred within two to
four weeks, depending on the dose administered.
Pooled data across dose cohorts showed that
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 generated using MorphoSys' Ylanthia
antibody platform and is based on a target discovered by Galapagos.
IL-17C is a cytokine which has been related to dermal inflammation
and has been shown to be distinct from other members of the IL-17
cytokine family. MOR106 is the first publically known human
monoclonal antibody against IL-17C in clinical development
worldwide. MOR106 is an investigational drug and its safety and
efficacy are yet to be established.
It is expected that Phase 2 development with
MOR106 will be initiated in the first half of 2018.
Details of the oral presentation on MOR106 at
AAD 2018:Abstract #6753 - MOR106, an Anti-IL-17C mAb, a
Potential New Approach for Treatment of Moderate-to-severe Atopic
Dermatitis: Phase 1 Study.Session #F061 - Late-breaking Research:
Clinical TrialsDate: Saturday, February 17 from 1:00 PM - 3:00 PM
PT (10:00 PM - 0:00 AM CET) Place: Ballroom 20APresenter: Professor
Diamant Thaçi MD, Director of the Institute for Inflammation
Medicine at the University Clinic Schleswig-Holstein Campus
Luebeck
About ADAtopic 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 afflicted 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 atopic dermatitis
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 atopic dermatitis 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
collaborationMOR106 is an investigational fully human IgG1
monoclonal antibody currently being developed for treatment of
inflammatory diseases. It is the first publicly disclosed human
monoclonal antibody designed to selectively target IL-17C in
clinical development worldwide. 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 share
research and development costs equally, as well as all future
economics.
About MorphoSysMorphoSys a late-stage
biopharmaceutical company devoted to the development of innovative
and differentiated therapies for patients suffering from serious
diseases. Based on our proprietary technology platforms and
leadership in the field of therapeutic antibodies, we, together
with our partners, have participated in the development of more
than 100 therapeutic product candidates currently in R&D, 28 of
which in clinical development. Our broad pipeline spans two
business segments: Proprietary Development, in which we invest in
and develop product candidates, and Partnered Discovery, in which
we generate product candidates for our partners in the
pharmaceutical and biotechnology industries against targets
identified by our partners. 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. 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.
ContactMorphoSys AGAnke Linnartz, Head of
Corporate Communications & IR Jochen Orlowski, Associate
Director Corporate Communications & IRAlexandra Goller,
Associate Director Corporate Communications & IRTel: +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 the
mechanism of action and safety and efficacy profile of MOR106, or
regarding the timing, progress and/or results of clinical studies
with 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 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
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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