Mithra completes recruitment for addintional Estelle safety study

Mithra (Euronext Brussels: MITRA), a company specialized in Women's Health, announces that it has completed recruitment into a safety study to evaluate the effect of Estelle® on endocrine function (thyroid, adrenal), metabolic control (lipid and carbohydrate metabolism) as well as on a broad panel of hemostasic markers[1]. Estelle® is Mithra's combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estelle® is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada, the results of which are expected in Q3 2018 and Q1 2019, respectively.

This study, which is part of EMA's[2] regulatory requirements for a novel COC, is a single center, randomized, open-label, controlled, three-arm trial As comparators, the study will also analyze[3] COCs containing either 30 mcg ethinylestradiol (EE)/150 mcg levonorgestrel (LNG) or 20 mcg EE/3 mg DRSP. A total of 101 subjects have been enrolled for six 28-day treatment cycles, and results are expected  towards the end of H1 2018.

The Phase III Estelle® studies, E4 Freedom, are open-label single arm trials to assess the safety and efficacy of Estelle® in approximately 1,550 participants in Europe/Russia and 2,000 participants in the US/Canada over a period of 12 months. Patient enrolment in the Europe/Russia study is complete with enrolment in the US/Canada study ongoing. The US/Canada arm of the trial is making good progress with over 90% of the sites now actively recruiting.

François Fornieri, CEO of Mithra, commented: "We are pleased to confirm that we have finalized the recruitment for this additional safety study for Estelle®, and we expect that the study will corroborate earlier findings that indicate the potentially improved safety profile of Estelle® compared to current COCs. We look forward to the full results of the Estelle® Phase III studies, which are on track to report in Q3 2018 for Europe/Russia and in Q1 2019 for US/Canada."

Important information

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[1] Study reference MIT-Es0001-C201

[2] European Medicines Agency ; see "Guideline on Clinical Investigation of Steroid Contraceptives in Women"

[3] EE/LNG is a comparator required by the agencies. EE/DRSP is currently marketed as Yaz®.