Contact

  • | Estetrol

Mithra Announces Presentation of Positive Data on Estetrol (E4) Native Estrogen at NAMS 2023

  • Independent global leaders in medical research on women’s health, Professor Amanda Black and Professor Wulf Utian, to deliver two presentations each on E4
  • E4 is a key active pharmaceutical ingredient in Estelle® and Donesta® products
  • Differentiated efficacy and safety in contraception and postmenopausal symptoms from positive Phase 3 trials

Liege, Belgium, 27 September 2023 – 7:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces there will be four presentations on Estetrol (E4) native estrogen at the North American Menopause Society (NAMS) 2023 Annual Meeting, being held September 27-30 in Philadelphia, USA. E4 is a key active pharmaceutical ingredient in both Mithra’s marketed contraceptive Estelle® and its next generation hormone therapy product candidate for postmenopausal symptoms, Donesta®.

Amanda Black MD, MPH, FRCSC, Professor of Obstetrics and Gynecology at The University of Ottawa, will hold an independent oral presentation on the use of E4 for contraception and menopause. Dr. Black will be discussing the science and safety behind the use of E4 in the menopause at the opening symposium and will present some of the data on the effects of E4 on breast tissue.

Dr. Wulf Utian[1], MD, PhD, DSc, Executive Director Emeritus and Honorary Founding President of NAMS, who is considered to be one of the world’s authorities on menopause and women’s health, will hold an oral presentation on the Phase 3 results of E4 in postmenopausal symptoms. The data, from two multi-center, double-blind, placebo-controlled trials with 2,550 postmenopausal women aged 40-65, show beneficial effects from 12-week treatment with E4. These include a significant increase in high-density lipoprotein (HDL) – or “good” – cholesterol and a significant decrease in the ratio total of HDL cholesterol to low-density lipoprotein (LDL) “bad” cholesterol and lipoprotein. There was also a significant decrease in fasting plasma glucose and HbA1c average blood glucose (glycemia) level. Also observed were trends for decreases in insulin and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).

Dr. Black and Dr. Utian will each also hold poster presentations on E4 at NAMS 2023.

Graham Dixon, Chief Scientific Officer of Mithra, commented: “The data will demonstrate that E4 treatment has a favorable safety profile, including a low impact on normal and malignant breast tissue, thanks to its unique mode of action which means it has tissue selective activity, unlike all other estrogens. It has also been shown to be effective at decreasing vasomotor symptoms in postmenopausal women. The evidence clearly shows the potential of E4 to offer women differentiated options to support their independence during child-bearing years and maintain their health during menopause.”

Mithra has previously reported positive results from Phase 3 trials, showing strong efficacy and a favorable safety profile for contraception, for Estelle®, and separately, a statistically significant reduction in vasomotor symptoms, or hot flushes and night sweats, in postmenopausal women, with Donesta®.

Dr. David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are proud that Dr. Black and Dr. Utian, two globally recognized experts on women’s health, are presenting this clinical research on our exciting E4 developments. Our scientific founder, Professor Jean-Michel Foidart, was amongst the first to characterize and recognize the potential of this native and selective estrogen, which is produced by the human fetus during pregnancy, passing into maternal blood at relatively high levels and offering unique benefits. His research and development efforts allowed Mithra to develop and test E4 as the key innovative active pharmaceutical ingredient in Mithra’s oral contraceptive Estelle® and its Donesta® next generation hormone therapy drug candidate.

Our marketing partners are currently accelerating the ongoing commercial launches of Estelle®, globally; we are finalizing our application for U.S. marketing authorization of Donesta®, for submission later this year. These data presented at NAMS 2023 illustrate the significant goals we are pursuing to provide women with a new era in oral contraception and the next generation hormone therapy for menopause. Our mission is for these and other innovative products to improve women’s health and independence from young adulthood through mid-life and beyond.”

Details of the presentations at NAMS 2023 are as follows:

  • Estetrol (E4): A Promising New Treatment for the Spectrum of Menopausal Symptoms
    Presenter: Amanda Black – Poster
  • The Effect of Estetrol (E4) on Patient-Reported Outcome Measures in Postmenopausal Women – Results From a Phase 3 Trial
    Presenter: Wulf Utian – Poster
  • Estetrol (E4), a Promising New Treatment for Menopausal Vasomotor Symptoms (VMS): Beneficial Lipid and Carbohydrate Metabolism in a Phase 3 Randomized, Double-blind, Placebo-Controlled Trial
    Presenter: Wulf Utian – Oral
    Time: 4:30-4:45pm EST, Thursday 28 September
    Location: Concurrent Session 2—Oral Abstract Presentations; Grand Ballroom (A–D)—Fifth Floor
  • Estetrol (E4) for contraception and Menopause: Where is the Science?
    Presenter: Amanda Black – Invited Oral (Independent)
    Time: 10:10-10:30am EST, Wednesday 27 September
    Location: Opening Symposium—Precision Oncology for Midlife Women; Grand Ballroom (E–L)—Fifth Floor

___

[1] Dr. Utian is a member of the Mithra Advisory Board.

 

Download press release

PDF version

Share it

Latest news

View all

Don't miss our news

Get the latest news: subscribe to our newsletter!

Subscribe
Go to Newsroom
Contact

Disclaimer

Please read this carefully as it applies to all persons who visit this website. The following pages contain information relating to an offering and/or admission to trading on a regulated market in relation to securities of Mithra Pharmaceuticals SA ("Mithra Pharmaceuticals"). This information may not be accessed by residents of certain countries based on applicable securities law regulations. Accordingly, if you wish to access this part of the website you must first inform yourself about and then observe the statutory and regulatory requirements applicable to you and to your jurisdiction. In order to establish whether or not you may view the information and documents please read the disclaimer below in full.

THIS WEBSITE AND THE MATERIALS CONTAINED THEREIN ARE NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW.

This website and the information contained herein or to which it gives access are not intended for, and may not be accessed by, or distributed or disseminated to, persons resident or physically present in the United States of America (including its territories, the "United States"), Australia, Japan or South Africa, and do not constitute, or form part of, an offer or invitation to sell or issue, or a solicitation of an offer or invitation to purchase or subscribe for, nor shall there be any sale or purchase of, any securities of Mithra Pharmaceuticals in the United States, Australia, Japan or South Africa or in any other jurisdiction in which such offer, invitation, solicitation, sale, issue, purchase or subscription would be unlawful prior to registration, unless an exemption from registration or qualification under the securities laws of any such jurisdiction is applicable. The securities of Mithra Pharmaceuticals referred to on this website have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be offered or sold in the United States absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act. There will be no public offering of Mithra Pharmaceuticals' securities in the United States.

All persons residing outside of the United States, Australia, Canada, Japan and South Africa who wish to access the documents contained on this website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this website, or require registration or approval for any acquisition of securities by them. Mithra Pharmaceuticals assumes no responsibility if there is a violation of applicable law and regulations by any person.

No action has been taken by Mithra Pharmaceuticals that would permit an offer of Mithra's securities or the possession or distribution of the materials to which this website gives access or any other offering or publicity material relating to Mithra's securities in any jurisdiction where action for that purpose is required.

Mithra Pharmaceuticals has not authorised any public offering in any Member State of the European Economic Area. With respect to any Member State of the European Economic Area that has implemented Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time (together with any applicable implementing measures in such Member State, the "Prospectus Regulation"), this website and the information contained herein, or to which it gives access, is only addressed to, and is only directed at, qualified investors in that Member State within the meaning of the Prospectus Regulation.

In addition, in the United Kingdom, this website and the information contained herein, or to which it gives access, is addressed to, and directed only at: (a) persons who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), and (b) high net worth entities, and other persons to whom they may otherwise lawfully be communicated, falling within article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). In the United Kingdom, any investment or investment activity to which this website and the information contained herein, or to which it gives access, relates, is available only to Relevant Persons and will be engaged in only with Relevant Persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this website and the information contained herein, or to which it gives access.

If you are not permitted to view materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Access to electronic versions of these materials is being made available on this webpage by Mithra Pharmaceuticals in good faith and for information purposes only.

By checking the acceptance box below, you confirm and certify that: You are not a resident of or physically present in the United States, Australia, Canada, Japan or South Africa or any other restricted jurisdiction, and that you are either: (a) a resident of, and domiciled in, a Member State of the European Economic Area and a qualified investor within the meaning of the Prospectus Regulation, (b) a resident of, and domiciled in, the United Kingdom, a qualified investor within the meaning of the Prospectus Regulation and a Relevant Person, or (c) otherwise authorised to access this information pursuant to applicable laws or regulations.

Abort