Mithra completes recruitment for addintional Estelle safety study

Safety study is part of the development of Estelle®, Mithra's combined oral contraceptive candidate / Aim of the study is to analyze a broad range of safety parameters for Estelle®, including hemostatic, endocrine and metabolic markers

(PresseBox) ( Liège, Belgium, )
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

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

[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®.
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