Xspray Pharma AB announced new clinical data from its XS003 registration study program. XS003 is an amorphous, non-crystalline formulation of nilotinib designed to overcome significant limitations of currently marketed crystalline formulations. In the announced study, XS003 demonstrates matching bioavailability to Tasigna, with a 50% reduced dose.

XS003 is designed to reduce food interactions for nilotinib, that currently complicate prescribing and adherence to existing therapies which may increase the risk of sudden death caused by prolongation of the QTc interval, for which Tasigna carries a boxed warning. Crystalline PKI formulations often lead to a substantial portion of the drug being unabsorbed and excreted, ending up in the sewage system. The results show that the XS003 amorphous formulation of nilotinib uses less than 50% of the active ingredient compared to crystalline forms. Thus, there is significantly less excess material available for overdosing, potentially making it a safer drug.