MediGene puts clinical phase I study with RhuDex® on hold
Volunteers suffered a heart problem after one of the scheduled treatments of RhuDex
MediGene AG has put an ongoing phase I study involving the drug candidate RhuDex® on hold. According to information obtained by MediGene, one of the volunteers participating in the study suffered a heart problem some days after one of the scheduled treatments of RhuDex®. The patient was subsequently treated in hospital and discharged a few days later. Several days after being discharged the volunteer unfortunately died at home. Investigations into the cause of death will be carried out but it is currently unclear whether or not there is any correlation between this sad event and the drug administration.
MediGene reported the event immediately to the relevant authorities and is investigating the possible causes of this event in coordination with the authorities. So far, about 80 individuals have been treated with this drug candidate and no comparable events occurred in the other subjects in this study or in previous clinical studies. Furthermore in extensive and relevant preclinical programs no signs of cardiac effects due to RhuDex® was observed. The eleven other volunteers included in the current phase I study showed only mild side effects like headaches. For the time being, the current study has been put on hold.
The phase I study concerned is investigating the bioavailability (drug concentration in the blood after administration) of RhuDex® in a new formulation. Recently, MediGene announced positive safety data for RhuDex® in a phase IIa trial in patients with rheumatoid arthritis.
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