Ascelia Pharma AB (publ) announced that the image reading phase has started as planned and re-confirms the May 2024 timeline for headline results from SPARKLE, the pivotal Phase 3 study for the orphan diagnostic drug candidate Orviglance®. Interaction with the FDA has not led to changes in the plans for the re-evaluation. As part of the preparations for the SPARKLE image re-evaluation, the new independent readers have successfully completed the training program according to plan.

The image reading process has now started and the first patient images have been evaluated. The re-evaluation is on track to report headline results by May 2024, as previously communicated. Ascelia Pharma has also interacted with the FDA in relation to the need for a re-evaluation.

Based on this, no changes to the re-evaluation process were made. Ascelia Pharma successfully completed patient enrollment in the Phase 3 study for Orviglance in March 2023. In early August, it was discovered that high intra-reader variability in the study image scoring by the independent radiologists prevented evaluation of the efficacy data from SPARKLE.

Due to this finding, a new evaluation of the images with new independent readers was decided and is now underway. The purpose of the re-evaluation of the SPARKLE images is to obtain a scientifically valid and reliable result from the SPARKLE study. A positive result would together with the other available data support a regulatory approval for Orviglance.