en
svFirst study group has been dosed in Xspray Pharma’s ongoing pivotal registration studies with HyNap-Dasa
Press release 2020-07-03
Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces that all healthy volunteers now have been dosed in the first of the two studies to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel® (dasatinib). The first group is conducted under fasting conditions and the second group is conducted under fed conditions.
The two bioequivalence studies are performed in healthy volunteers under fasting and fed conditions, respectively. All subjects in the first study group have now been fully dosed. The second study, under fed conditions, has been initiated and is expected to be fully dosed in the coming weeks. In both studies, HyNap-Dasa bioequivalence is compared to that of the original drug Sprycel®. The preliminary results from the first study are expected in August 2020.
The results of the two clinical trials, together with the results of the ongoing stability studies on the final tablets on HyNap-Dasa, will form the basis of the Company’s first market approval application in the USA.
“This means that we, in spite of the Covid-19 situation, are one step closer to the date of filing for market approval in the US with our first product candidate and we will now initiate our search for commercial partners or purchasers for HyNap-Dasa. We are currently preparing for this process together with our legal and financial advisors and I feel confident that we will be well prepared for a more intensified process following the release of the clinical results,” says Per Andersson, CEO Xspray. “Completing the trials with HyNap-Dasa will free up capacity for us to work more intensively with the next products in our portfolio, an improved version of HyNap-Dasa and HyNap-Nilo, which both will follow the 505(b)(2) regulatory pathway.”