April 21, 2016 / 7:58 am, CEST
Bimagrumab Did Not Meet Its Primary Endpoint in Patients with sIBM
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its partner Novartis has confirmed that a phase 2b/3 study examining bimagrumab (BYM338) in sporadic Inclusion Body Myositis (sIBM) did not meet its primary endpoint. Data are currently being reviewed and will inform decisions on the bimagrumab development program. Ongoing clinical trials are not being discontinued at this time.
"The outcome of the phase 2b/3 study with bimagrumab in sIBM is disappointing. Nevertheless, ongoing clinical trials, including those in sarcopenia and hip fracture are continuing as planned at this stage", said Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Our collaboration with Novartis has produced eleven clinical programs to date with many more to come. We are looking forward to continuing to see more successful products arising from our collaboration with Novartis."
sIBM is a rare debilitating muscle disease, characterized by progressive weakness and wasting of the muscles. Over time, patients can lose the ability to walk, experience falls and injuries, lose hand function and have swallowing difficulties.
About bimagrumab (BYM338)
Bimagrumab (BYM338) is a novel human monoclonal antibody developed to treat pathological muscle loss and weakness. BYM338 was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys, whose Human Combinatorial Antibody Library (HuCAL) was used to identify the antibody.
In addition to sIBM, bimagrumab is in clinical development for hip fracture recovery and sarcopenia, a disease characterized by age-related low muscle mass and functional impairment. Bimagrumab is administered by intravenous infusion.
About Sporadic Inclusion Body Myositis (sIBM)
Sporadic Inclusion Body Myositis (sIMB) is a rare, progressive muscle disease characterized by weakness and wasting of the proximal muscles (core muscles, closest to the body's midline), typically the knee flexors, and distal muscles (affecting muscles further on the limbs), mainly finger flexors, and pharyngeal muscles (affecting swallowing). Diagnosis of sIBM is complex, and there is no single test that enables reliable diagnosis; because of this, sIBM is often misdiagnosed. The disease mostly affects people older than 50 years, and patients may become wheelchair dependent within 10-15 years of disease onset. There is currently no approved treatment for sIBM.
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.
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.
For more information, please contact:
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Associate Director Corporate Communications & IR
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404