maj 11, 2022

Ectin Research AB: amendment approved by regulatory authorities – clinical study to start according to plan

Ectin Research AB (“Ectin” or “the Company”) recently announced that it had submitted a formal amendment to its study protocol to regulatory authorities. The main reason for this was a change in the protocol due to the fact that Tamro, the company’s supplier of study medicines, had to contract a new manufacturer for one of the medicines. Now, both the Swedish Medical Products Agency and Ethical Review Authority have approved the amendment. The goal of initiating the study at a clinical trial site in June 2022 remains.

The company has previously announced that Tamro, the company’s supplier of study medicines, has had to contract a new manufacturer of one of the study medicines. This in turn led to the need for a formal change (a so-called ‘amendment’) in the study protocol submitted to regulatory authorities (the Medical Products Agency and the Ethical Review Authority). Approval of the amendment and thereafter of the corresponding biobank application is required before the study can be initiated at the trial site. Now both the Medical Products Agency and the Ethical Review Authority have returned with an approval of the amendment. This means that the corresponding biobank application can now be submitted to the relevant authority. Once this approval is in place, and local clinic preparations at the test site are completed, the study can be initiated, which is expected to take place in June 2022.