deCODE suspends Ph III trial of GD031

Iceland-based deCODE genetics has voluntarily suspended a Phase III clinical trial of DG031 (veliflapon), its developmental compound for the prevention of heart attack, in order to address an unexpected formulation problem with the tablets being used in the trial.

According to deCODE, routine testing of clinical supplies 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. The firm says it has presented the issue to the US Food and Drug Administration and is exploring alternative manufacturing processes.