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news.MorphoSys has completed a first dosing regimen in a Phase I clinical study on healthy volunteers of the HuCAL-derived antibody MOR103 with no adverse events reported.
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Six healthy volunteers in the first dosing group have been enrolled and received MOR103 injections, while three volunteers received placebo. The safety review of the medical data from the lowest dosing group yielded a determination that it was safe to proceed with the second dosing group.
The randomized, double-blind, placebo-controlled, single-ascending dose trial will be conducted in approximately 50 healthy volunteers and is being conducted in a clinical pharmacology unit in Utrecht, the Netherlands. The trial is scheduled to be finalized in 2008 and final reporting is expected in the first quarter of 2009.
The company’s lead development program, MOR103, is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate.
Marlies Sproll, chief scientific officer of MorphoSys, said: “Antibodies that neutralize GM-CSF could represent a new generation of medicines that reduce inflammation with greater beneficial effects.”