Xspray to present data at ASCO highlighting frequent comedication of PPIs with TKIs in CML-patients and greater than expected negative effects on the bioavailability of crystalline dasatinib

Rhea-AI Summary

Xspray Pharma presented compelling data at the ASCO Annual Meeting, highlighting significant issues in the co-medication of Proton Pump Inhibitors (PPIs) with Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia (CML) patients. The study revealed that 54% of CML patients treated with TKIs also received a PPI, with 66% of these comedications prescribed by different healthcare providers. The bioavailability of crystalline dasatinib was significantly affected, with a 96% reduction in Cmax and an 88% reduction in AUC24 when co-medicated with a PPI. To address this, Xspray plans to launch Dasynoc®, an optimized version of dasatinib, by September 2024.

Positive

• Xspray's innovative Hynap technology aims to improve cancer treatment by developing optimized versions of marketed drugs.
• The study's findings on the negative impact of PPIs on dasatinib bioavailability were presented at a prestigious event, ASCO Annual Meeting.
• Data showed substantial reductions in bioavailability when dasatinib is co-medicated with PPIs, emphasizing the need for alternative treatment options.
• Xspray is on track to launch Dasynoc®, an optimized version of dasatinib, by September 2024, potentially improving clinical outcomes for CML patients.
• The company's collaborative efforts with Uppsala University and the Karolinska Institute demonstrate robust research partnerships.

Negative

• High prevalence of PPI co-medication with TKIs (54% of CML patients), which can significantly reduce the effectiveness of dasatinib.
• 66% of PPI prescriptions were given by different healthcare providers, indicating potential miscommunication issues in patient treatment regimens.
• The bioavailability of crystalline dasatinib was significantly compromised, with a 96% reduction in Cmax and an 88% reduction in AUC24 when co-medicated with PPIs.
• Potential adverse effects on business from highlighting significant issues with current dasatinib formulations could affect investor confidence until Dasynoc® is launched.

• 54% of TKI-treated CML-patients received a PPI
• 66% of concomitant prescribing was by a different healthcare provider
• Crystalline dasatinib Cmax and AUC24 reduced by 96% and 88% respectively

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a Swedish pharmaceutical company which uses its innovative Hynap technology to develop 505(b)(2) improved versions of marketed drugs for the treatment of cancer announced today the online publication of its abstract titled “Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability” for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 3^rd, 2024 at 9-12 AM, Poster nr. 120 (1).

While Tyrosine Kinase Inhibitors (TKI), including dasatinib, have profoundly improved clinical outcomes in patients with chronic myeloid leukemia (CML), the bioavailability and systematic exposure of the crystalline formulation of dasatinib is reduced by comedication with acid reducing agents which may affect the clinical response and comedication with proton pump inhibitors, such as omeprazole, should be avoided (2).

The collaborative analysis with Uppsala University and the Karolinska Institute and University Hospital demonstrates that 54% of CML patients identified in the Swedish CML-register were prescribed at least one PPI and 34% of TKI-treated patients were comedicated with a PPI. Of those prescribed a PPI, 66% of the prescriptions were by a different healthcare provider. Further, the presentation provides new information on the bioavailability of crystalline dasatinib when comedicated with a PPI, demonstrating a substantially higher than previously reported impact of PPIs on the bioavailability of crystalline dasatinib, with C_max and AUC₂₄ being reduced by 96% and 88% respectively.

“Consistent absorption and bioavailability of dasatinib are critical for adequate disease control and patient outcomes, this is however often overlooked in clinical practice as our data demonstrates,” said Per Andersson, CEO of Xspray. “To address this important issue, we are on track to launch Dasynoc^®, our optimized version of dasatinib, with a Prescription Act Use Fee Amendment date (PDUFA-date) of 31^st of July 2024 and the US commercial launch of Dasynoc on 1^st September 2024.”

The abstract is now available online at https://meetings.asco.org/2024%20ASCO%20Annual%20Meeting/15766?presentation=239588#239588

References:

1. Dahlén T, Larfors G, Lennernäs H et al. Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability. American Society of Clinical Oncology, Annual Meeting 2024. Chicago. Abstract 6561. Poster 120. https://meetings.asco.org/2024%20ASCO%20Annual%20Meeting/15766?presentation=239588#239588
2. Sprycel^® (dasatinib) Tablets for oral use. Labeling, Supplement 27. 02 Aug 2023. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021986. Accessed 22 May 2024.

About Xspray Pharma AB

Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240523850369/en/

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

What did Xspray present at the ASCO Annual Meeting?

Xspray presented data on the significant impact of Proton Pump Inhibitors (PPIs) on the bioavailability of crystalline dasatinib in CML patients.

What is the impact of PPIs on dasatinib's bioavailability?

Co-medication with PPIs resulted in a 96% reduction in Cmax and an 88% reduction in AUC24 for crystalline dasatinib.

When is Xspray planning to launch Dasynoc®?

Xspray plans to launch Dasynoc® on September 1, 2024, following its PDUFA date on July 31, 2024.

What percentage of TKI-treated CML patients received a PPI?

54% of TKI-treated CML patients received a PPI.

Who collaborated with Xspray on the presented study?

Xspray collaborated with Uppsala University and the Karolinska Institute and University Hospital on the study.