Xspray Pharma announces the results of two bioequivalence studies with adjusted tablet formulation of HyNap-Dasa (ANDA)

Regulatory press release 2021-04-08

Xspray Pharma AB (publ), (Nasdaq Stockholm: XSPRAY) announces today the preliminary results of two bioequivalence study on fasting and non-fasting healthy volunteers using a slightly adjusted tablet formulation of the generic product candidate HyNap-Dasa “B”. In the study on non-fasting subjects, bioequivalence with Sprycel was achieved. In the study on fasting subject’s lower absorption was achieved, however the effect was not enough to achieve bioequivalence. The bioequivalence studies with a more modified version of HyNap-Dasa, the “C” formulation, is scheduled to commence in Q2 with preliminary results in Q3 2021. This formulation will further lower the absorption levels as displayed in laboratory testing.

The current HyNap-Dasa tablet formulations and bioequivalence studies are:

  • HyNap-Dasa “A”, the first formulation, where the results were announced in the second half of 2020 and in January 2021
  • HyNap-Dasa “B”, the minor modification of tablet formulation that is now being tested
  • HyNap-Dasa “C”, the larger modification of the tablet formulation; bioequivalence studies are scheduled to commence in Q2

“With this tablet formulation, HyNap-Dasa “B”, we have succeeded in lowering absorption compared to the previous formulation, but not enough to achieve bioequivalence for the fasting group. The results confirm that we are working with the correct formulation tools but show that we need to make larger modifications to reduce the uptake of dasatinib in order to compensate for the low absorption of Sprycel. The next study will be conducted with HyNap-Dasa “C”, which displayed positive results in laboratory testing. Our opinion is that we now have excellent chances of achieving bioequivalence,” says Per Andersson, CEO of Xspray Pharma.

The bioequivalence studies were conducted using the HyNap-Dasa “B” tablet formulation. The results show that the formulation lowers absorption compared to “A”, but that formal bioequivalence was not achieved in the study with fasting subjects. As previously, there was great variation in the uptake of dasatinib in the group that received Sprycel®, where several subjects also displayed low absorption of dasatinib. HyNap-Dasa “B” demonstrated a significantly more even uptake, and no subjects displayed low absorption. As previously, bioequivalence was achieved with subjects who received food, with good margins.