mars 28, 2022

Ectin Research AB updates timeline for start of combined phase I / II study

Ectin Research AB (“Ectin” or “the Company) has previously announced the target of initiating the clinical study of MFA-370 for the treatment of metastatic urothelial bladder cancer during Q1 2022. The company now announces that the study will be initiated during Q2 2022. The main reason for this is a change in the study protocol due to the availability of one of the study medicines. The company also announces that initiatives have now been taken to include more countries in the study (Denmark, Lithuania and Germany). The goal of delivering topline results from the first part of the study, phase I, at the end of Q4 2022 remains.

 The company has previously announced that it has received both the Swedish Medical Products Agency’s and the Swedish Ethical Review Authority’s regulatory approval to conduct a phase I / II study of MFA-370 for the treatment of patients with metastatic urothelial bladder cancer. The Phase I / II study was expected to begin in Q1 2022.

Due to problems in the subcontracting chain with the company’s supplier of the required study medicine, Tamro AB has now contracted a new producer of the medicine in question. This in turn entails the need for a formal change (a so-called amendment) in the study protocol submitted to regulatory authorities. Approval of this change, and of the corresponding biobank application, is now required before the study medicine can be distributed to test sites and the study initiated.

In the company assessment this change does not constitute any risk to the regulatory authorities’ decision to approve initiation of the study. The company’s plan is to send in the necessary documents during the first half of April. Updated approvals are expected in May and the study is thus planned to be initiated in June.

To enable the initiation of the phase I part of the combined phase I / II study within the previously set time frames, i.e. with the aim of being able to use results from the phase I part at the end of Q4 2022 and then be able to make a decision to start phase II, the company has, together with LINK Medical Research AB, identified additional countries and clinics to include in the study. The company therefore plans to submit regulatory applications in three more countries; Denmark, Lithuania and Germany, in Q2 2022.

The company also plans to continue to recruit patients from the previously mentioned four countries during the phase II part of the combined phase I / II study, instead of, as previously announced, from three European countries in order to be able to increase the recruitment rate in the study.