Early data from Mithra’s ESTELLE® pediatric study to be presented at two upcoming congresses

  • Abstracts accepted to the ESC Bilbao and EURAPAG Thessaloniki congresses
  • The study provides insights into safety, compliance, and bleeding profiles of ESTELLE® contraceptive use in post-menarchal adolescents, raising no new safety concerns

 

Liege, Belgium, 16 April 2024 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health is proud to announce the acceptance of an abstract presenting the design and findings of a pediatric study involving ESTELLE®, Mithra’s first product based on estetrol (E4), at two renowned congresses.

ESTELLE®, Mithra’s first E4-based product is commercialized as a combined oral contraceptive in the US and Canada under the brand name NEXTSTELLIS® and in Europe by Gedeon Richter as DROVELIS®.

The abstract, showcasing the pediatric study conducted in adolescents, has been accepted for oral presentation at both the ESC Bilbao (1-4 May 2024) and EURAPAG Thessaloniki (5-8 June 2024) congresses. The presenting authors are esteemed experts in the field: Prof. Kristina Gemzell-Danielsson will present at ESC Bilbao, while Prof. Dan Apter will present at EURAPAG Thessaloniki.

Combined oral contraceptives (COCs) such as ESTELLE® are widely used among adolescents for contraception1, as well as cycle and bleeding control. However, despite their popularity2, clinical data specific to this age group remains limited.

To address this gap, Mithra undertook this study under a Pediatric Investigation Plan (PIP) agreed with the European Medicines Agency (EMA) to conduct a phase 3, open-label, single-arm study across 23 centers in Europe (MIT-Es001-C303, ClinicalTrials.gov: NCT04792385, EudraCT: 2019-003002-27). The study aimed to assess the safety and tolerability of ESTELLE® in healthy post-menarchal females aged 12 to 17 years over six cycles.

Out of 145 initially screened participants, 112 were enrolled, with 89 completing the study. The last subject’s last visit was concluded in November 2023. The mean age of participants was 15.2 years, with most being first-time users of oral contraceptives and/or experiencing dysmenorrhea.

The study provides valuable insights into the safety, compliance, and bleeding profiles of ESTELLE® in post-menarchal adolescents. Importantly, no new safety signals were observed.

We are very pleased to share the findings of our pediatric study at these prestigious congresses,” said Graham Dixon, Chief Scientific Officer of Mithra, “This research underscores our commitment to advancing the understanding of women’s health and ensuring the safety and efficacy of our products for all age groups.

Additionally, medicines authorized across the EU with results from a PIP included in the product information are eligible for a six-month extension of their supplementary protection certificate.

 

___

1 Jones RK. Beyond birth control: the overlooked benefits of oral contraceptive pills. New York, NY : Guttmacher Institute; 2011

2 Todd N and Black A Contraception for Adolescents J Clin Res Pediatr Endocrinol 2020;12(Suppl 1):28-40

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.