deCODE Suspends Phase III Trial of DG031 to Improve Tablet Manufacturing
Thursday October 5, 6:35 pm ET
REYKJAVIK, Iceland, Oct. 5 /PRNewswire-FirstCall/ -- deCODE genetics (Nasdaq: DCGN - News) today announced that it is voluntarily suspending its Phase III clinical trial for DG031 (veliflapon), the company's developmental compound for the prevention of heart attack, in order to address an unexpected formulation problem with the tablets being used in the trial. Routine testing of clinical supplies has revealed that over time the tablets appear to dissolve more slowly. Pharmacokinetic data indicates that to date this has not affected drug exposure nor raised any safety concerns, but the company is 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 Food and Drug Administration (FDA) and is exploring alternative manufacturing processes. A conference call to discuss today's announcement will be webcast live tomorrow, Friday, October 6, at 8:00 a.m. Eastern Time/12 noon GMT/1 p.m. British Summer Time (details below).
"Faced with this problem, we felt that our only option was to put the trial on hold and improve the formulation of the tablets. This is the right thing to do both for patients and for the company, who have a common interest in successfully developing drugs to prevent heart attack. We are leading the way in targeting the leukotriene pathway to this end, and will continue our other therapeutic and diagnostic programs in heart attack as we work to develop new clinical supplies of DG031," said Kari Stefansson, CEO of deCODE. |
