The British volunteer who recently died after taking part in a Phase I trial of RhuDex, the CD80 inhibitor under development by MediGene for rheumatoid arthritis, had suffered a number of small myocardial infarctions over previous years, the company said.

MediGene was reporting on the findings of an autopsy conducted by the Department of Pathology at the University of Edinburgh on Peter Munro, the local man who suffered a heart problem some days after taking RhuDex and subsequently died at home after being discharged from hospital. The Phase I trial was put on hold.

The autopsy showed that Munro died of an acute myocardial re-infarction as a result of coronary thrombosis, the German biotech noted. It also revealed coronary arteriosclerosis and myocardial hypertrophy going back several years.

“These findings clearly prove impairment of cardiac function in this patient that had developed for many years,” the company stated. From MediGene’s point of view, this supported “the assessment that a causal correlation between the death of the patient, which MediGene deeply regrets, and the administration of the trial medication is unlikely”.

According to MediGene, the Phase I protocol included a comprehensive analysis of the volunteers’ cardiac and vital functions both before and after administration of RhuDex. All the same, it added, small infarctions “may occur without chest pain and may remain unrecognised by the affected persons and undiagnosed in subsequent clinical examinations”.

Until the circumstances of Munro’s death have been clarified definitively, MediGene “continues to actively support the investigations in close co-operation with the authorities, which after closing their examinations will decide about further continuation of the [RhuDex] clinical trial programme”, it commented.