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Xspray Pharma has released new clinical data for its second product candidate, XS003, which shows matching bioavailability to Tasigna at more than a 50% lower dose.
XS003 is designed to overcome limitations of current crystalline formulations of nilotinib, a protein kinase inhibitor used in cancer treatment.
The new data suggests that XS003 may reduce the risk of sudden death caused by QTc interval prolongation, a known complication with Tasigna, by minimizing food interactions.
The company aims to complete the pivotal clinical program within this year and submit an FDA approval application by the first half of 2025, despite a slight delay in the study's processing time.
XS003's amorphous formulation could also reduce environmental impact by decreasing the amount of unabsorbed drug excreted.
CEO Per Andersson expressed satisfaction with the progress, emphasizing the potential safety benefits of using a reduced dose.
Xspray Pharma presented compelling data at the ASCO Annual Meeting, highlighting significant issues in the co-medication of Proton Pump Inhibitors (PPIs) with Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia (CML) patients. The study revealed that 54% of CML patients treated with TKIs also received a PPI, with 66% of these comedications prescribed by different healthcare providers. The bioavailability of crystalline dasatinib was significantly affected, with a 96% reduction in Cmax and an 88% reduction in AUC24 when co-medicated with a PPI. To address this, Xspray plans to launch Dasynoc®, an optimized version of dasatinib, by September 2024.
