september 7, 2022

Ectin Research AB postpones start of clinical study

Following Ectin Research AB’s (”Ectin” or the ”Company”) planned rights issue – announced today, September 7th, 2022 – the Board of Directors of Ectin has decided to postpone the start of the Company’s clinical Phase I/II trial until capital raised from the rights issue is in place. The Company expects to resume the study in December 2022, provided that the rights issue is completed as planned and provides the required capital.

Clinical Phase I/II trial

Ectin announced in June of the current year, 2022, that all required regulatory approvals had been obtained in Sweden for the Company’s combined clinical Phase I/II trial of its drug candidate MFA-370 for the treatment of metastatic urothelial bladder cancer, and that two trial sites for the study had been contracted in Sweden and one in Denmark. The company also announced that the process of initiating the trial site in Sweden had started in June and that this would be completed after the summer, after which patient recruitment would begin.

During the summer, all regulatory approvals were also obtained in Denmark and Lithuania. Furthermore, the German regulatory authority Bfarm has also approved the Phase I/II study. The company is now working on finalising approvals in Germany and finalising contracts with additional trial sites in the different countries. Initiation of the trial sites is now planned for December 2022.

Given that funding for the full Phase I part of the study needs to be in place prior to enrollment of patients in the study, the study has been delayed. The Board believes that the study will be able to resume in December 2022, and be completed in the summer of 2023, provided the required capital is raised via the planned rights issue.

Anna Sjöblom-Hallén, CEO Ectin: ”Ectin has been working intensively on preparations for the Phase I/II study, so having to postpone the start of the study is not a wished-for scenario, however we have a responsibility towards the patients to ensure that the Phase I part of the study can be fully implemented. In the meantime, we are making every effort to create the best conditions to ensure that when it resumes the study will run at a good pace.”