The experimental drug is said to have caused a severe inflammatory reaction and multiple organ failure in some of the trial participants. The company that was developing the drug has not officially been named but is believed to be TeGenero AG, a small German pharmaceutical company.
Eight men took part in this stage of the clinical trial; six were given the product and two were given a placebo. Two of the men are believed to be critically ill and remain in intensive care while the other four are said to be showing signs of improvement.
“Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken,” said Professor Kent Woods, chief executive officer of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The news highlights the risks of participation in drug trials and may make it even more difficult for pharmaceutical companies to enroll healthy patients in early-stage trials.