The analysis is based on modeling and simulation of data from a comparative study in healthy volunteers. The developed PopPK model, which simulates repeated dosing until steady state is reached, shows a strong correlation with observed concentrations – supporting its regulatory relevance.

The results confirm formal bioequivalence between XS003 and Tasigna in terms of systemic exposure (AUC and Cmax) – despite the XS003 dose being less than half that of the reference drug. In addition, a clinical study has shown that XS003 has significantly improved food interaction and a more predictable dose response, which can facilitate precise dose adjustments in clinical practice. Previously communicated data showed that bioavailability increased by only 28% with food intake – compared to up to 82% for Tasigna. This absorption stability with food intake may reduce the risk of concentration-dependent side effects, such as abnormal heart rhythm (QTc prolongation), particularly in real-world settings where strict fasting can be difficult to maintain

“The data announced today form the pivotal foundation for our regulatory submission with XS003, this confirms our HyNap™ platform which can create bioequivalent improved formulations with significantly lower dosing and stable absorption even with food intake. This represents a crucial step forward in our strategy to expand the commercialization of our products,” says Per Andersson, CEO of Xspray Pharma.

With these results, Xspray Pharma plans to submit a NDA application in the near future. XS003 will be the company’s second product candidate submitted for FDA approval following Dasynoc, both based on the HyNap™ technology: An innovative amorphous formulation technique that has shown potential to improve absorption for a range of products including protein kinase inhibitors.