Ascelia Pharma AB (publ) (ticker: ACE) today announced the results of the Food Effect Study that evaluated the effect of food intake on absorption and signal intensity of Orviglance®. The results showed that intake of a light meal 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 confirmed robust image enhancement of the liver after Orviglance administration compared to an MRI image without a contrast agent. A patent application has been filed on these new findings.
“We are very pleased to conclude that the intake of a light meal does not impact image enhancement of the liver compared to a fasting condition. This further improves the convenience and ease the administration of Orviglance in clinical practice. The results from the study also support our previous knowledge about the image enhancement that Orviglance provides to MRI scans”, said Carl Bjartmar, Chief Medical Officer of Ascelia Pharma.
In this crossover study, Orviglance was administered to 24 healthy volunteers in fasting condition and in one of two conditions with food intake (either light meal or full meal). The image enhancement effect was measured as the change in the MR signal intensity before and after (1, 4, 8 and 24 hours) administration of Orviglance. The results showed that a light meal prior to Orviglance administration provided similar image enhancement when compared to a fasting condition, whereas the image enhancement was less pronounced for the group receiving a full meal. The strongest signal intensity occurred 4 hours after administration, which is in line with what has been observed in previous studies.
The Food Effect Study forms part of Orviglance ongoing pivotal clinical program and the results will be included in the marketing authorization submission package to the health authorities including FDA and EMA.
Ascelia Pharma has filed a patent application based on the results of the study.