deCode Pharmaceuticals Suspends Phase III Trial of Heart Attack Drug DG031 Due to Formulation Issues
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.
DG031 is a drug candidate designed to lower the risk of heart attack by inhibiting genes encoding proteins in the leukotriene pathway, thus reducing the production of leukotriene B4, a potent driver of inflammation. deCode has already notified the FDA of the manufacturing issues and is now exploring alternative manufacturing processes.
Meanwhile, the firm will continue their other programs aimed at decreasing the risks for heart attack.
Source: deCode
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