Xspray Pharma AB (NASDAQ Stockholm: XSPRAY), a biopharmaceutical company focused on the development of high-performance, amorphous forms of tyrosine kinase inhibitors (TKIs), presented two posters examining the pharmacokinetics of XS004-dasatinib in healthy volunteers at the 64th meeting annual of American Society of Hematology (ASH), December 10-13 in New Orleans, USA.
“The treatment of CML has been revolutionized by tyrosine kinase inhibitors (TKIs), yet many patients are still not receiving their full clinical benefit. Our data suggest that the amorphous solid dispersion formulation of dasatinib – XS004, manufactured with HyNap technology, has the potential to reduce variability in drug exposure and unleash the full therapeutic power of TKI for more patients. We welcome the opportunity to present our findings for XS004 to the international CML community at ASH, the world’s largest and leading conference venue in hematology,” he says Tommaso ValzCMO of Pharmaceutical xspray.
Xspray in collaboration with researchers from Uppsala University & Karolinska University Hospital, presented two posters examining the pharmacokinetics of XS004. Dr. Larfors et al. demonstrated that XS004 absorption is less sensitive to pH than crystalline dasatinib, demonstrating that XS004 may be more compatible for co-administration with acid-reducing agents. In a separate presentation, Dr. Lennernas et al. shared data from a Phase 1 bioavailability study demonstrating that inter- and intrasubject variability in plasma drug concentration was reduced for XS004, compared with crystalline dasatinib. The enhanced biopharmaceutical properties of XS004 may lead to reduced exposure outside the therapeutic window with the potential to reduce the risk of adverse events and optimize the therapeutic efficacy of dasatinib.
“Concomitant use of TKIs and antacid agents is widespread in CML. By reducing the pH sensitivity of TKIs, we believe this can help more patients benefit from the treatment,” says Per Andersson, CEO of Pharmaceutical xspray.
The 2 posters are available for download:
- Concomitant therapy with proton pump inhibitors and dasatinib is common in CML but XS004, a new amorphous solid dispersion formulation of dasatinib, provides improved absorption and low pH-dependence, minimizing unwanted drug interactions
- XS004 Dasatinib (XS004) Improves Variability and Bioavailability in Humans Using Dasatinib Amorphous Solid Dispersion Formulation with Potential Implications for Its Clinical Use
“I believe these findings represent an important step forward in addressing the real-world challenges associated with crystalline TKIs,” said Dr Leif Stenk of the Karolinska University Hospital.
The United States Food and Drug Administration (FDA) granted XS004 orphan drug designation for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). XS004 is currently under review by the FDA for market approval under the NDA 505(b)(2) regulatory pathway.