MARTINSRIED / MUNCHEN, GERMANY--(Marketwire - September 20, 2012) -
MorphoSys AG / MorphoSys's MOR103 Antibody Demonstrates Excellent Safety
and Efficacy in Rheumatoid Arthritis Patients.
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Results from Phase 1b/2a Trial Show Substantial Reduction of RA Symptoms
on ACR and DAS28 Disease Scores
* Primary and secondary endpoints of the study successfully met
* MOR103 showed excellent safety data at all doses administered
* First anti-GM-CSF antibody to demonstrate proof-of-concept in patients
* ACR20 score of up to 68% at week 4
* Strong onset of therapeutic effect as early as 2 weeks
* Anti-inflammatory effects supported by MRI analysis
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced
from the phase 1b/2a clinical trial evaluating its proprietary HuCAL
MOR103 in rheumatoid arthritis (RA) patients. The positive data make
first anti-GM-CSF antibody to demonstrate clinical efficacy in RA. The
demonstrate the compound's potential to become an important new drug in an
of unmet medical need. MorphoSys will submit a late-breaking abstract
forthcoming conference to present the clinical trial results before the
"We are very excited by the results of the study," commented Dr.
Schottelius, Chief Development Officer of MorphoSys AG. "The ACR20 score
amongst the highest seen for a biological compound in RA after four
treatment. The excellent efficacy and safety data we observed underline
potential to become a first-in-class treatment modality for RA patients,
novel and differentiated mechanism of action. We expect to present the
the most relevant medical conference for RA later this year. The quality
data demonstrates the capabilities of our discovery and development
and mark a significant step in MorphoSys's strategy to bring innovative
The best response was achieved in the 1.0 mg/kg dose cohort with an ACR20
of 68% at week 4, which was significantly higher than in the
(p < 0.0001). Of particular importance was the fast onset of action
within 2 weeks, up to 40% of patients achieved an ACR20 score.
DAS28 scores was rapid and significant over the treatment period of the
MRI scans revealed a reduction of synovitis according to the RAMRIS
MOR103 was safe and well-tolerated at all doses administered. There
drug-related serious adverse events. No obvious differences in the adverse
rate between the MOR103 and placebo groups were observed.
"These are excellent results," commented the principal investigator
study, Professor Harald Burkhardt, Professor of Rheumatology and Head
Division of Rheumatology at Frankfurt University. "Considering the short
in-patient study, MOR103 demonstrated very promising clinical activity and
onset of action with favorable safety data."
In the randomized, double-blind, placebo-controlled phase 1b/2a trial in 96
to moderate RA patients, MOR103 was administered in four weekly
0.3 mg/kg, 1.0 mg/kg or 1.5 mg/kg. The trial, which was designed to
particular at the onset of the therapeutic effect, was conducted in 26
in Germany, Netherlands, Poland, Bulgaria and Ukraine. The majority of the
participants were on a stable regimen of disease modifying anti-rheumatic
The primary endpoint of the trial was to determine the safety and
of multiple doses of MOR103 in patients with active RA. Secondary
measures were pharmacokinetics, immunogenicity, and the drug's
improve clinical signs and symptoms of RA as measured by DAS28,
EULAR response criteria, MRI imaging for synovitis and bone edema as
patient reported outcomes.
Based on these compelling data, MorphoSys will now proceed with its
seek a commercial partner for further development of the program. In
the RA study, MOR103 is currently being evaluated in a phase 1b dose-
study in multiple sclerosis. Results of a phase 1 pharmacokinetic
healthy volunteers to evaluate a subcutaneous formulation of MOR103
Overview of Study Results:
|Results at day 28 |Placebo| MOR103 | MOR103 | MOR103 |
|(Majority of | | [0.3 mg/kg] | [1.0 mg/kg] | [1.5 mg/kg] |
|patients were on | | | | |
|stable regimen of | | | | |
|DMARDS) | | | | |
|Number of patients | 27 | 24 | 22 | 23 |
|Proportion of | | | | |
|patients achieving | 7% | 25% | 68% | 30% |
|ACR20 | | | | |
|Proportion of | | | | |
|patients achieving | 4% | 4% | 23% | 9% |
|ACR50 | | | | |
MorphoSys will hold a public conference call and webcast tomorrow,
September 21, 2012 at 03:00 p.m. CEST (09:00 a.m. EST, 02:00 p.m.
present more information on the results of the MOR103 clinical trial.
Dial-in number for the Conference Call (listen-only):
Germany: +49 89 2444 32975
For U.K. residents: +44 20 3003 2666
For U.S. residents: +1 202 204 1514
Please dial in 10 minutes before the beginning of the conference.
In addition, MorphoSys offers participants the opportunity to
presentation through a simultaneous slide presentation online
A live webcast, slides, webcast replay and transcript will be made
MOR103 is a fully human antibody against GM-CSF (granulocyte macrophage-
stimulating factor). GM-CSF was originally identified as a growth factor
granulocytes and macrophages but has more recently been identified as an
inflammatory mediator in autoimmune disorders such as RA. GM-CSF stimulates
cells to produce granulocytes and other macrophages and subsequently
these differentiated immune cells leading to an increased production of
inflammatory cytokines, chemokines and proteases and thereby ultimately to
articular destruction. The antibody MOR103 blocks GM-CSF and reduces its
About clinical trials in RA:
Rheumatoid arthritis, or RA for short, is traditionally considered a
inflammatory autoimmune disorder that causes the immune system to attack
joints and affects in particular a membrane, called synovium, which lines
movable joint. It is a disabling and painful inflammatory condition, which
lead to substantial loss of mobility due to pain and joint destruction. The
disease affects approximately 4-6 million people worldwide. To analyze the
effect of a compound in a clinical trial in RA, disease scores such as ACR-
measure summarizing improvement in the number of tender and swollen joints,
scale, patients' and physicians' assessment of improvement and certain
laboratory markers - and DAS28 scores are used. ACR 20 describes the
of study participants who achieved a 20 percent improvement in tender or
joint counts as well as 20 percent improvement in three other disease-
criteria. For the DAS28 score 28 swollen joints and 28 tender joints are
MorphoSys developed HuCAL, the most successful antibody library technology
the pharmaceutical industry. By successfully applying this and other
technologies, MorphoSys has become a leader in the field of therapeutic
antibodies, one of the fastest-growing drug classes in human healthcare.
company's AbD Serotec unit uses HuCAL and other antibody technologies to
generate superior monoclonal antibodies for research and diagnostic
Together with its pharmaceutical partners, MorphoSys has built a
pipeline of more than 70 human antibody drug candidates for the treatment
cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few.
its ongoing commitment to new antibody technology and drug development,
MorphoSys is focused on making the healthcare products of tomorrow.
listed on the Frankfurt Stock Exchange under the symbol MOR. For regular
about MorphoSys, visit http://www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®,
and Ylanthia® and 100 billion high potentials® are registered
Slonomics® is a registered trademark of Sloning BioTechnology
subsidiary of MorphoSys AG.
This communication contains certain forward-looking statements
MorphoSys group of companies. The forward-looking statements contained
represent the judgment of MorphoSys as of the date of this release and
risks and uncertainties. Should actual conditions differ from the
assumptions, actual results and actions may differ from those
MorphoSys does not intend to update any of these forward-looking
far as the wording of the relevant press release is concerned.
Media Release: http://hugin.info/130295/R/1642624/529145.pdf
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