Xspray Pharma’s XS003 Study Shows Matching Bioavailability to Tasigna at More than a 50% Lower Dose
09 Julio 2024 - 11:52AM
Business Wire
Xspray Pharma provides an update on its second product
candidate, XS003: New data shows matching bioavailability to
Tasigna® at more than a 50% reduced dose.
Xspray Pharma AB (Stockholm/Nasdaq: XSPRAY), a biotechnology
company focused on developing improved protein kinase inhibitors
(PKIs) for cancer treatment using its proprietary HyNap™
technology, announced today new clinical data from its XS003
registration study program. XS003 is an amorphous, non-crystalline
formulation of nilotinib designed to overcome significant
limitations of currently marketed crystalline formulations. In the
announced study, XS003 demonstrates matching bioavailability to
Tasigna, with a 50% reduced dose.
XS003 is designed to reduce food interactions for nilotinib,
that currently complicate prescribing and adherence to existing
therapies which may increase the risk of sudden death caused by
prolongation of the QTc interval, for which Tasigna carries a boxed
warning.
“We are very pleased with the progress of our second product
candidate, XS003. Our goal is to complete the pivotal clinical
program within this year and submit the approval application to the
FDA in the first half of 2025. This represents a slight delay
caused by an unexpectedly long processing time by the authority in
the study country, which has now been resolved," said Per
Andersson, PhD, CEO of Xspray Pharma.
Crystalline PKI formulations often lead to a substantial portion
of the drug being unabsorbed and excreted, ending up in the sewage
system. The results show that the XS003 amorphous formulation of
nilotinib uses less than 50% of the active ingredient compared to
crystalline forms. Thus, there is significantly less excess
material available for overdosing, potentially making it a safer
drug.
About XS003
XS003 demonstrated these results in a comparative
bioavailability study involving healthy volunteers. It is Xspray's
second product candidate developed using the HyNap™ technology.
XS003 is being developed under the 505(b)(2) NDA process, which
streamlines the approval process, and is expected to be submitted
to the FDA in the first half of 2025. In 2020, XS003 received
orphan drug status from the FDA for the treatment of chronic
myeloid leukemia (CML). US sales for Tasigna approached $1.2
billion in 2023.
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Kerstin Hasselgren Senior Advisor & Investor Relations
Xspray Pharma AB Mob: +46 (0) 70 311 16 83 E-mail:
kerstin.hasselgren@xspray.com