All participants in Xspray Pharma’s study have received their dose of the improved version of dasatinib
Press release 2021-06-28
Xspray Pharma (Nasdaq Stockholm: XSPRAY) announces today that all participants have received their dose of the company’s improved amorphous version of dasatinib for the bioequivalence study. The study is being conducted on fasting healthy volunteers with the objective to demonstrate that a lower dose strength of Xspray Pharma’s improved version of dasatinib will have the same uptake as a higher dose strength of the original market-approved drug. Previous studies have shown that Xspray Pharma’s formulation has demonstrated lower variability, that it is not affected by the pH value in the stomach and therefore enables simultaneous therapy with proton-pump inhibitors (PPIs) such as omeprazole. The preliminary results are expected during the third quarter and will form the basis of an application for market approval in the US under the 505(b)(2) regulatory pathway.
“A major advantage of our amorphous formulations is that they are easier to be absorbed by the body, which enables us to lower the strength of the dose while still improving therapy for patients, in particular the large patient group that is also affected by, for example, peptic ulcers, and therefore requires PPI therapy, something that should be avoided with the original drug,” says Per Andersson, CEO of Xspray Pharma.
Xspray Pharma’s improved version of dasatinib is developed for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), an area in which no new or improved drugs have been registered for several years.