DeCode: Stop-and-go phase III trial
Reykjavik – The Icelandic biotech company deCode Genetics has voluntarily stopped its most advanced clinical project (DG031) for the treatment of heart attack due to an unexpected formulation problem. As the company said, the tablets used in the study appeared to dissolve more slowly than expected and the company had concerns that this could affect the trial’s success.
DeCode’s drug development covers common diseases such as heart attack, thrombosis or asthma. The company is specialized in genetic research, based on the scientific exploitation of the Icelandic Genealogic Database. The heart attack compound DG031 (veliflapon) is the most advanced project and according to the company the phase III trial will re-start in “several months”. The issue will be presented to the FDA and alternative manufacturing processes are explored. Nevertheless, the stop-and-go-procedure seems to have produced an financial gap: In November, the company raised a62million on the sale of convertible notes due in 2011.