MorphoSys partner Novartis has confirmed that a phase IIb/III 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 IIb/III 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. "Our collaboration with Novartis has produced 11 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.
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.
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 to 15 years of disease onset. There is currently no approved treatment for sIBM.