september 1, 2021

Ectin Research receives approval from Medical Products Agency for phase I / II study of MFA-370 in the treatment of metastatic urothelial bladder cancer.

In July 2021, Ectin Research submitted its clinical trial application (CTA) to the Medical Products Agency for its planned clinical phase I / II study of patients with metastatic urothelial bladder cancer to be treated with the drug candidate MFA-370. The Medical Products Agency has now granted Ectin Research a CTA. The study is planned to be initiated during H2 2021 and where the first patient begins to be dosed H1 2022.

Current treatments for metastatic urothelial bladder cancer require long, repeated stays in hospital, with only a limited clinical effect – 5-year survival in the patient group is only 5%. Today’s established treatments also often causes severe side effects that can significantly reduce the patient’s quality of life.

Ectin Research’s innovative cancer treatment MFA-370 is taken orally and is a combination of two well-established drugs with few and tolerable potential side effects. Ectin Research has now been granted permission to proceed with a phase I / II study of MFA-370 in Sweden in patients with metastatic urothelial bladder cancer.

The first part, the phase I study, is primarily intended to examine safety and tolerability and also to determine the recommended phase II dose. Phase I comprises 24 weeks of treatment with MFA-370 in approximately 10 patients in Sweden. If the results from the phase I study show that the treatment has an acceptable side-effect profile, phase II will be initiated.

The phase II part is primarily focused on determining the clinical effect (”overall response rate” ORR) after 24 weeks of treatment with MFA-370 in approximately 30 patients in Sweden and two other countries in Europe. An interim analysis of the “clinical benefit rate” (CBR) will be performed after 12 patients in phase II have undergone MFA-370 treatment.

In order to maintain a satisfactory recruitment rate of patients during the course of the study, Ectin Research plans to submit additional CTAs in two other European countries during H2 2021, together with the Contract Research Organization LINK Medical Research AB. The clinical phase I / II study is planned to be initiated during H2 2021 where the first patient begins dosing H1 2022 and the study is expected to last until H2 2024. Thereafter, the patients are followed for another 6 months to follow up the treatment result.

Ectin Research’s CEO Anna Sjöblom-Hallén: ”We are extremely pleased with the development of this project and the Medical Products Agency’s decision, which means that we can now follow our plan for the clinical development of MFA-370, a safer and more effective treatment for metastatic urothelial bladder cancer.”