STOCKHOLM – Xspray Pharma AB today present the results of a clinical pilot study regarding the drug candidate HyNap-Dasa. The pilot study examined HyNap-Dasa’s bioavailability of dasatinib, the cancer drug currently marketed as Sprycel, for the treatment of chronic myeloid leukemia (CML). The two critical parameters for the absorption of dasatinib in the body, AUC and Cmax, were in the studied HyNap-Dasa compositions found to be in close range of those observed with Sprycel. The company intends to, barring minor adjustments, bring a chosen HyNap-Dasa composition further and introduce it as a generic product to the US market (in accordance with regulatory ANDA procedure).
In the clinical Phase I trial, where 12 healthy subjects participated, the bioavailability for different compositions of HyNap-Dasa were tested in comparison to Sprycel. The results are positive and confirm the validity of Xspray’s formulation tool. The studies needed in order to be able to bring HyNap-Dasa to final registration studies will now be performed as previously planned.
“I am very pleased that we achieved the primary purpose of the study which was to provide support for our product composition for planned studies during the first half-year 2018. The study shows that the achieved absorption profile of our HyNap-Dasa-composition is similar to the original drug and that the formulation tool we have developed works for adjusting both AUC and Cmax to the levels required for showing bioequivalence. This is an important step in the development of our generic drug based on our RightSize™-technology. We now have a clear picture of how the formulation should be composed for future studies. This makes it very probable that we will keep our timetable for the registration studies planned in future,” says Per Andersson, CEO.
Summary of the clinical results:
- The overall bioavailability of dasatinib from HyNap-Dasa, measured as the area under the curve (AUC) was 7% higher for the HyNap-Dasa composition compared to Sprycel.
- The maximum concentration of dasatinib in plasma (Cmax) was 13% higher for the HyNap-Dasa composition compared to Sprycel.
- The results show that formal bioequivalence (Cmax and AUC within the range 80-125% of the original drug) can be achieved with a larger number of subjects.
The study results are in line with the company’s clinical development plan as described in the prospectus presented in connection with the introduction on First North at the end of September. The plan is to carry out the necessary studies in order to be able to have a complete product approved for sale on the US market 2020 or by 2021 at the latest.
For further information, please contact:
Per Andersson, CEO, Xspray Pharma AB (publ)
Mobile: +46 (0)706 88 23 48
About Xspray Pharma
Xspray Pharma AB (publ) is a product development company with several product candidates under clinical development. Xspray uses its innovative RightSize-technology in order to develop improved and generic versions of already marketed cancer drugs, primarily protein kinase inhibitors (PKI), for treating cancer. The segment is the second largest within the oncology department and the drug prices are very high. Through its innovative technology, Xspray can enter the market as first competitor to the original drugs available today without the hindrance of secondary patents. Xspray’s goal is to ha three products ready for launch on the American market during the period 2020-2023, with a first product launched at the latest by 2021. The company has patents on production technology, equipment and the resulting products. The shares in Xspray Pharma (publ) are traded on Nasdaq First North Growth Market Stockholm and Redeye is the Certified Adviser for the company.
This information is information that Xspray Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above, at the above stated time.
Xspray Pharma AB (publ)
Gunnar Asplunds Allé 326
171 63 Solna