Ascelia Pharma AB (publ) (ticker: ACE) today announced that due to the Russian invasion of Ukraine, all clinical activities in Russia in the ongoing Phase 3 study SPARKLE are being suspended. As a consequence, the expected recruitment completion for the SPARKLE study is extended to 2022 (previously H1 2022).
The consequences of Russia’s invasion of Ukraine are both grave and concerning. Because of the escalating situation, Ascelia Pharma has decided to suspend all clinical activities, including patient enrolment, in Russia. We are mindful of the patients and the Russian medical staff with whom we have worked with.
Ascelia Pharma is committed to completing the SPARKLE study as fast as possible. We are working with the already active study hospitals to accelerate enrolment as well as expanding the number of participating hospitals.
Among the 47 clinical sites currently open in the SPARKLE study globally, 13 are located in Russia. The decision to suspend clinical activities in Russia may extend the timeline for completing patient recruitment in the study. The expected recruitment completion is therefore extended to 2022 (previously H1 2022). As previously communicated, Ascelia Pharma has sufficient financing to complete the SPARKLE study.