Recent stability results detected particulate matter in clinical batches of the intravenous formulation of Fodosine. Preliminary findings have suggested that the particulates are associated with the vial stoppers used in clinical packaging and may result from an interaction between a component of the stopper and a component of the drug solution.
The trial was examining the intravenous form of Fodosine in patients with patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). BioCryst and Mundipharma jointly develop Fodosine.
The oral capsules being used in other clinical trials of Fodosine are not affected and those trials will continue, the company said.
BioCryst said the data do not suggest any decrease in the potency of the Fodosine active drug product. An internal investigation is ongoing and patient treatment has been halted.
The company also said that data from phase IIa trial of Fodosine suggests that response rates appear to have decreased from those previously reported, although data is still being collected for analysis.