Xspray Pharma has reported positive data from a Phase I study of HyNap-Dasa in comparison with Sprycel for the treatment of cancer, after meeting the trial's primary goal.
The trial compared the pharmacokinetic parameters, including Cmax and area under the curve (AUC), for Sprycel and two different HyNap tablet formulations of dasatinib.
During the trial, a total of 16 healthy subjects received single doses of each of the study product in a cross-over design.
Results from the trial have validated its primary aim to demonstrate bioequivalence of an optimised formulation of HyNap-Dasa against Sprycel, a dasatinib chemotherapy medication that is currently being marketed for the treatment of chronic myeloid leukaemia (CML).
Xspray Pharma said that it will leverage the results to design its planned registration study for an abbreviated new drug application (ANDA) of the US Food and Drug Administration (FDA).
Xspray Pharma CEO Per Andersson said: “The outcome of this study represents an important milestone for Xspray Pharma as it means that we now can initiate the preparation of the pivotal phase of the clinical programme, taking us closer to a commercial launch of HyNap-Dasa.
“Furthermore, the results pave the way also for additional product candidates in our pipeline. It signifies a new and important step in our development as a company.”
Xspray Pharma uses its RightSize technology to develop improved and generic versions of available cancer drugs, primarily protein kinase inhibitors (PKIs) for use in the treatment of cancer.
The company has identified three PKIs as the first product candidates, including HyNap-Dasa, HyNap-Sora and HyNap-Nilo.