Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces today that it has received positive preliminary results from a bioavailability study in healthy volunteers with an improved HyNap-Dasa version of the reference drug Sprycel™, demonstrating that absorption of HyNap-Dasa is not dependent on the gastric pH level. HyNap-Dasa is being developed both as a generic and improved version of the marketed drug Sprycel® (dasatinib).
The preliminary results from the bioavailability study demonstrates that solubility and absorption of Xspray Pharma’s amorphous version of dasatinib, HyNap-Dasa, is not dependent on the gastric acidity (pH level). Xspray Pharma has earlier announced positive preliminary data for a sub-group of the subjects in the study.
As disclosed in Sprycel® US labelling, the uptake is dependent on the patient’s gastric acidity. Increased pH dramatically decreases dasatinib´s solubility and absorption. The results from Xspray Pharma’s clinical study show that HyNap-Dasa is not affected during omeprazol treatment which increases the gastric pH. The results from the current conducted study shows a minor absorbtion increase of 8%, measured as area under the curve (AUC) after treatment with 40 mg of omeprazole (proton pump inhibitor) daily for five days. This can be compared to publiced data for Sprycel® where AUC was reduced by 43% in combination with omeprazole. In 2019, Sprycel® was the leading drug for the treatment of chronic myeloid leukaemia (CML) in sales, with global and US sales of 2,11 and 1,19 billion dollar, respectively.
“We have now demonstrated that our amorphous HyNap-Dasa formulation, produced in our commercial supply chain, can eliminate the pH dependent absorption seen in the crystalline reference product. This will allow for long-lasting acid suppressing medication also for CML patients treated with dasatinib. There are also patients with no production of hydrochloric acid in the stomach (achlorhydria) resulting in high gastric pH. These patients will have the chance to get a better dasatinib product for their cancer therapy,” says Per Andersson, CEO of Xspray Pharma. “For many of the amorphous drug candidates we decide to develop, we will have the possibility to develop either a generic or an improved version, or both where we see a clinical and commercial rationale. This makes multiple registration pathways also for our lead product candidate possible and will not only increase Xspray Pharma’s value proposition to potential partners, but also broaden the commercial possibilities for Xspray Pharma as a company”.