Publication date: 08/02/2018
Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that the company obtained promising results for its Phase II hemostasis study of Estelle®, Mithra’s combined oral contraceptive (COC) candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).
The Phase II study1, which is a substudy running in parallel with the ongoing pivotal Phase III studies for Estelle®, analyzes an extensive series of hemostatic, endocrine function and metabolic control parameters, in compliance with regulatory guidelines. 2 The results are very important to further define the unique safety potential of Estelle® and in particular its biological impact on hemostasis: the parameters analyzed are widely accepted as surrogate markers of coagulation (blood clotting) and fibrinolysis (breakdown of clots). Hence, an analysis of these markers is key to help determine the risk profile of a novel COC for deep vein thrombosis (DVT) and pulmonary embolism, which are well-documented side effects of certain contraceptive pills. Therefore, the results are closely studied by the regulatory bodies and keenly awaited by clinicians and (potential) commercialization partners for Estelle®.
Given their importance, Mithra plans to present the hemostasis data at the following highly
regarded scientific conferences:
François Fornieri, CEO Mithra Pharmaceuticals, commented: “We are pleased with the results from the hemostasis study, which are very promising indeed. With our Phase III trials in Europe/Russia and US/Canada well underway, the results of the hemostasis study corroborate earlier findings that Estelle® may present a unique benefit/risk profile, offering the potential of a true ‘next generation’ contraceptive option for women.”
Estelle® is Mithra’s novel oral contraceptive product candidate composed of 15 mg Estetrol (E4), its unique native estrogen, and 3 mg DRSP. Currently, pivotal Phase III Estelle® trials (E4 Freedom) are ongoing in Europe and Russia as well as in the US and Canada, with top line results expected in Q3
2018 and Q1 2019, respectively. The E4 Freedom studies are open-label single arm trials to assess the safety and efficacy of Estelle® in over 1,550 participants in Europe/Russia and approximately 2,000 participants in the US/Canada, over a period of 13 cycles.
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 a 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 Mithra CDMO. Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart and is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com