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news.Decode Genetics has suspended its phase III clinical trial for DG031 for the prevention of heart attack, as a result of a formulation problem with the tablets used in the trial.
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The tablets were discovered to dissolve more slowly after a period of time during routine testing, the company said. Data indicates that this has not affected drug exposure nor raised any safety concerns.
However, Decode said they were concerned that this change may eventually cause the tablets to release too little drug, potentially limiting the effect of the compound and undermining the trial’s chances of success.
Decode has presented the issue to the FDA and is exploring alternative manufacturing processes.
“Faced with this problem, we felt that our only option was to put the trial on hold and improve the formulation of the tablets,” said Kari Stefansson, CEO of Decode.
DG051, the company’s other developmental compound for the prevention of heart attack is now in phase I clinical testing. Decode is also using its discoveries to develop diagnostic tests to gauge individual risk of heart attack.