Xspray to present ASCO data on PPI-TKI comedication's impact on dasatinib bioavailability in CML patients

Xspray Pharma AB, a Swedish pharmaceutical company that utilizes its advanced Hynap technology to enhance existing cancer drugs, has announced the online publication of a significant abstract titled “Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability.” This abstract will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 3rd, 2024.

Tyrosine Kinase Inhibitors (TKIs), such as dasatinib, have significantly improved clinical outcomes for patients suffering from chronic myeloid leukemia (CML). However, the bioavailability and systemic exposure of dasatinib, particularly its crystalline form, are notably reduced when patients are also taking acid-reducing agents like proton pump inhibitors (PPIs). This interaction can detract from the clinical efficacy of the TKI treatment, making it essential to avoid PPI comedication.

A collaborative study involving Uppsala University, the Karolinska Institute, and University Hospital analyzed data from the Swedish CML register. The findings revealed that 54% of the CML patients treated with TKIs were prescribed at least one PPI, and 34% of these patients were taking both a TKI and a PPI concurrently. A striking 66% of the PPI prescriptions were issued by a healthcare provider different from the one prescribing the TKI.

This study also provided new insights into the impact of PPIs on the bioavailability of crystalline dasatinib. Previous reports had indicated a negative effect, but the recent data suggests that the reduction in bioavailability is far more severe, with the peak concentration (Cmax) and the area under the curve over 24 hours (AUC24) of dasatinib reducing by 96% and 88%, respectively, when taken alongside a PPI.

Per Andersson, CEO of Xspray Pharma, emphasized the importance of consistent absorption and bioavailability of dasatinib for effective disease management and patient outcomes. He noted that this critical issue is often overlooked in clinical settings. In response to this challenge, Xspray Pharma is preparing to launch Dasynoc®, an optimized version of dasatinib. Dasynoc® has a Prescription Drug User Fee Act (PDUFA) amendment date set for July 31, 2024, and is scheduled for commercial release in the U.S. on September 1, 2024.

Xspray Pharma's mission is to develop superior versions of marketed cancer drugs using its HyNap™ technology platform, aiming to improve the efficacy, safety, and patient experience associated with these treatments. The company's shares are publicly traded on Nasdaq Stockholm, showcasing its commitment to enhancing cancer therapy outcomes.

The abstract detailing these findings is now available online. This new research underscores the importance of considering drug-drug interactions in CML treatment and highlights Xspray Pharma’s proactive approach to addressing such clinical challenges with innovative drug formulations.