Ascelia Pharma AB (publ) announced that new data show that the pivotal Phase 3 clinical SPARKLE study with the lead candidate drug Orviglance can be completed with 80 patients, with a complete patient enrollment expected in Feb-Mar 2023 and a subsequent topline readout by mid-2023. New data with the same image reading methodology as in the SPARKLE study with Orviglance demonstrate a strong and statistically significant effect of two to three times the effect level previously expected in SPARKLE. Therefore, a statistically significant positive outcome is likely to be obtained with substantially fewer patients, while maintaining conservative assumptions.

Ascelia Pharma has thoroughly analyzed the new data and original assumptions with statisticians and regulatory experts to validate this important finding. Ascelia Pharma has discussed the analysis with the US Food and Drug Administration (FDA) with the objective to decide on a smaller sample size in SPARKLE than initially planned. Based on these discussions, Ascelia Pharma has decided to change the patient enrollment target of SPARKLE to 80 patients.

Years of pandemic impact on clinical trial activities at hospitals, a change of Clinical Research Organization following a bankruptcy, and the discontinuation of 13 clinical sites in Russia are all factors that have significantly influenced patient enrollment in SPARKLE. In recent months, patient enrollment has shown a positive trend based on the opening of additional study sites and a launch of patient enrollment initiatives. To date, 58 patients have completed the study.

Ascelia Pharma expects to complete SPARKLE patient enrollment by February/March 2023 with topline results by mid-2023. are also committed to providing updates on SPARKLE patient enrollment after the last Friday every month. Two of the three clinical studies of the Phase 3 program for Orviglance are completed with successful results.

The previously announced Food Effect study successfully concluded that Orviglance image enhancement was not impacted by a light meal. The Hepatic Impairment Study showed that Orviglance is well tolerated in patients with liver (hepatic) impairment. The completion of SPARKLE will finalize the Phase 3 program.