German biotechnology company MorphoSys' partner Novartis is set to begin its Phase II clinical trial of bimagrumab to treat obese patients with type 2 diabetes.
Bimagrumab is a human combinatorial antibody library (hucal) antibody developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys to treat pathological muscle loss and weakness.
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The HuCAL library of Morphosys was used to identify the antibody. It fuses with high affinity to type II activin receptors thereby preventing natural ligands from binding, including myostatin and activin and stimulate muscle growth by inhibiting signalling from these inhibitory molecules.
The Phase II clinical trial will be conducted as a randomised, subject-blinded and investigator-blinded study to test the safety, efficacy and determine pharmacokinetics profile of bimagrumab compared with placebo by intravenously administering bimagrumab to 60 obese adult patients diagnosed with type 2 diabetes.
The study is primarily focused on determining alteration in fat body mass after completing 24 weeks and then 48 weeks of treatment.
The secondary endpoints of the study are to measure baseline change in HbA1c, insulin resistance to be determined on the basis of the homeostatic model assessment (HOMA-IR), fasting insulin and glucose.
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By GlobalDataMorphoSys chief scientific officer Dr Marlies Sproll said: "We are very excited that our partner Novartis is taking bimagrumab into a phase II study in type 2 diabetes, an indication with growing demand for novel treatments.
“This new study will join phase II clinical trials of bimagrumab currently ongoing in patients with sarcopenia and after hip fracture surgery.”
