21 June 2017
MITHRA COMPLETES RECRUITMENT FOR ADDITIONAL 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
Liège, Belgium, 21 June 2017 – 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. 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 regulatory requirements for a novel COC, is a single center, randomized, open-label, controlled, three-arm trial As comparators, the study will also analyze COCs containing either 30 μg ethinylestradiol (EE)/150 μg levonorgestrel (LNG) or 20 μg 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.
 Study reference MIT-Es0001-C201
 European Medicines Agency ; see “Guideline on Clinical Investigation of Steroid Contraceptives in Women”
 EE/LNG is a comparator required by the agencies. EE/DRSP is currently marketed as Yaz®.
“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.”
François FornieriCEO of Mithra
For more information, please contact:
Sofie Van Gijsel, IRO
+32 485 19 14 15
Consilium Strategic Communications
Jonathan Birt, Sue Stuart, Philippa Gardner, Hendrik Thys, Cameron Standage
+44 2 037 095 700
Chief Communication Officer
+32 4 349 28 22 / +32 475 86 41 75
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women’s Health, with a particular focus on fertility, contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® – are built on Mithra’s unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO.
Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com
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