Xspray Pharma provides an update on how the Covid-19 pandemic affects the company’s planned clinical studies

Regulatory press release 2020-04-15

STOCKHOLM – April 15, 2020. Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) announces that the start of the pivotal clinical bioequivalence studies with HyNap-Dasa are expected to be postponed by two to three months due to the Covid-19 pandemic.

Xspray Pharma's planned clinical trials are, like the trials of many other drug developing companies, affected by the ongoing COVID-19 pandemic. The clinical bioequivalence studies in healthy volunteers with HyNap-Dasa that were planned to commence in the beginning of Q2 2020 are now expected to be postponed to begin by the end of Q2 2020.

“The results of the clinical studies, together with the results from the ongoing stability studies, which are continuing without delays, will form the basis of our ANDA application to the FDA. We have now postponed the start of the clinical studies as we want to feel confident that the studies can be completed without interruptions or drop-offs. This will lead to that the ANDA the application may be submitted later than planned as the results of the clinical trial are now time critical,” says Per Andersson, CEO of Xspray.

The clinical bioequivalence studies are conducted on healthy volunteers and the objective is to demonstrate that the company's first product candidate HyNap-Dasa is bioequivalent to Sprycel® (dasatinib). Together with the results of the ongoing stability studies, the data will form the basis of the company's ANDA application for market approval in the USA.

“In all other aspects, the HyNap-Dasa project is going according to plan. And I am very pleased that all our partners around the world can continue to work actively on our projects. As the clinical material for HyNap-Dasa is completed, we focus on getting results for the upcoming products in the pipeline, such as HyNap-Nilo,” concludes Per Andersson, CEO of Xspray.