Mithra Recognized by the Scientific Community: the Contraception Journal Publishes a Scientific Article About E4 (Estetrol) FIESTA Phase II Study

  • Mithra Pharmaceuticals announces today the publication of a scientific article based on the results of the E4 FIESTA Phase II study of its estetrol-based product candidate Estelle®, a combined oral contraceptive composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP).
  • The article describes the bleeding pattern and cycle control observed with different E4 combinations.
  • The published results are very interesting for the scientific community as they demonstrate the good bleeding profile of the Estetrol-based product candidate Estelle®, which will be confirmed in the coming phase 3 studies.

Liège, Belgium, 4 May 2016 – Mithra Pharmaceuticals announces today that an article has been published in the peer-reviewed Contraception Journal. The published results of the E4 FIESTA Phase II study are particularly encouraging for the imminent launch of the Phase III studies.

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Mithra’s European Advisory Board for Estelle Will Meet During the ESC Congress (European Society of Contraception) in Basel on May 4th 2016

  • Mithra has set up a scientific committee composed of international experts to support the last development steps of Estelle®, its contraceptive product candidate based on Estetrol.
  • The European or American scientific committees, set up by Mithra and its own scientific committee, are aimed at gathering impressions and recommendations from the international experts in the contraception field. These committees will be moderated by Mitchell Creinin, global expert in contraception of the Davis University in Sacramento, California.
  • During the ESC (European Society of contraception) held in Basel from May 5th to 7th, 2016, Mithra will gather its experts and practitioners board and will present the last results of the project Estelle to the scientific community during a symposium entitled “Estelle, new contraceptive pill with fetal estrogen, Estetrol”

Liège, Belgium, 3 May 2016 – In order to support the last development steps and to prepare its candidate product for a future introduction on the market, Mithra set up an international and European advisory committee. Composed of 7 international European experts in gynecology, this committee will advise Mithra on its development, but also on the clinical relevance and the added value of Estetrol in the contraception field. These Key Opinion Leaders will work with Mithra in order to confront development plans with market needs. The next committee meeting is planned on May 4th in Basel, Switzerland, during the ESC Congress (European Society of contraception and Reproductive Health) and will be moderated by Mitchell Creinin, a world expert in contraception.

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3 Out of 5 European Countries Selected Have Fully Approved Protocol of Phase II Clinical Study Donesta®-Mit-Do001-C201. 8 Out of 9 European Countries Selected Have Fully Approved Protocol of Phase III Clinical Studies Estelle®- Mit-Es001-C301.

  • The authorities of 3 out of 5 countries give green light to start the Phase II clinical study of the Estetrol-based product candidate dedicated to vasomotor menopausal symptoms (VMS) treatment on menopausal women (Donesta®) on their territories.
  • In parallel, Mithra announces: 8 out of 9 countries selected to host Phase III clinical trials for Mithra’s contraceptive product candidate based on Estetrol (Estelle®) in Europe have already fully approved the clinical trials protocol.
  • The progress of the clinical programs regarding the Estetrol-based products candidate (Donesta®and Estelle®) are in line with objectives and remains on Mithra’s schedule.

Liège, Belgium 29 April 2016 – On the 5 countries selected to host Phase II clinical trial for Mithra’s HRT (Hormone Treatment Therapy) candidate based on Estetrol (Donesta®) in Europe, 3 already fully approved the clinical trial protocol.

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