Xspray Pharma’s XS003 Study Shows Matching Bioavailability to Tasigna at More than a 50% Lower Dose
Xspray Pharma has released new clinical data for its second product candidate, XS003, which shows matching bioavailability to Tasigna at more than a 50% lower dose.
XS003 is designed to overcome limitations of current crystalline formulations of nilotinib, a protein kinase inhibitor used in cancer treatment.
The new data suggests that XS003 may reduce the risk of sudden death caused by QTc interval prolongation, a known complication with Tasigna, by minimizing food interactions.
The company aims to complete the pivotal clinical program within this year and submit an FDA approval application by the first half of 2025, despite a slight delay in the study's processing time.
XS003's amorphous formulation could also reduce environmental impact by decreasing the amount of unabsorbed drug excreted.
CEO Per Andersson expressed satisfaction with the progress, emphasizing the potential safety benefits of using a reduced dose.
- XS003 shows matching bioavailability to Tasigna at over 50% lower dose.
- Aims to complete pivotal clinical program this year and submit FDA application by H1 2025.
- XS003 may reduce risk of sudden death from QTc interval prolongation by minimizing food interactions.
- Potential for safer drug with less excess material available for overdosing.
- Slight delay in the study's processing time.
Insights
The data indicating that XS003 achieves the same bioavailability as Tasigna® at a more than 50% reduced dose is a significant milestone. Bioavailability measures how much of the drug reaches the bloodstream where it can have an effect and achieving this with a lower dose can potentially reduce side effects. Additionally, the reduced food interactions and safety profile are critical advantages. Reducing the risk of QTc interval prolongation, which Tasigna® carries a boxed warning for, is particularly noteworthy. This advancement could translate into better patient compliance and fewer treatment-related complications, addressing critical gaps in current cancer treatments. While the final clinical trial results and FDA approval will be decisive, this news is promising for both patients and healthcare providers.
From a financial perspective, achieving similar bioavailability at a lower dose is a compelling value proposition. This could lead to cost savings in production and potentially higher margins. Moreover, the prospect of completing the pivotal clinical program within the year and aiming for FDA approval by the first half of 2025 is a positive timeline for investors. However, investors should be cautiously optimistic given the slight delay mentioned. The market potential for an improved formulation of a drug already approved (Tasigna®) bodes well for Xspray Pharma’s future revenue streams. However, the company's ability to navigate the FDA approval process and bring XS003 to market will be critical for realizing these financial benefits.
In the highly competitive oncology market, differentiation is key. XS003's ability to reduce dose while maintaining efficacy positions it uniquely. The reduction of food interactions and improved safety profile can be strong selling points to both oncologists and patients. Additionally, the environmental benefits from less drug waste due to improved absorption could resonate well with sustainability-focused stakeholders. The delay mentioned might concern some investors, but the overall progress and the clear path to regulatory submission provide a solid foundation for long-term growth. Competition from other PKIs should not be underestimated, but Xspray’s proprietary HyNap™ technology offers a competitive edge that could carve out a significant market share.
Xspray Pharma provides an update on its second product candidate, XS003: New data shows matching bioavailability to Tasigna® at more than a
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
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
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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
Source: Xspray Pharma AB
FAQ
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