Ascelia Pharma AB (publ) is presenting results from its Orviglance Food Effect study at the RSNA conference 2022- 27 November - 1 December Chicago, Illinois). The study evaluates the effect of food intake on the absorption and signal intensity of Orviglance, a manganese-based MRI contrast agent, and successfully concludes that image enhancement is not impacted by a light meal. The Food Effect Study results show that intake of a light meal within 30 min prior to Orviglance administration provides similar image MRI enhancement of the liver compared to a fasting condition.

In line with previous studies, the data also confirms strong image enhancement of the liver after Orviglance administration compared to an MRI image without a contrast agent. In clinical practice, the results support administration of Orviglance both after fasting or after consumption of a light meal. The reporting of these final results for the Food Effect Study completes two of the three studies in Ascelia Pharma's ongoing Phase 3 clinical program for registration of Orviglance.

As previously announced, the Hepatic Impairment Study successfully concluded that Orviglance is well tolerated in patients with liver (hepatic) impairment. The plan for the ongoing Phase 3 study, SPARKLE, required for regulatory submission, is to complete patient enrolment by the end of this year. Data from the Food Effect Study will be included in the marketing authorization application to health authorities, including FDA and EMA.