Mithra to hold five presentations on key role of estrogens

Mithra to hold five presentations on key role of estrogens in women’s health, including Estetrol (E4), at the ESG Congress in Amsterdam

• Five abstracts on the positive effect of E4 accepted for oral presentation
• Eleven leading experts to outline why estrogen is critical in contraception and for the treatment of postmenopausal symptoms
• Data show promising efficacy and safety features of E4, key ingredient in ESTELLE^® and DONESTA^®

Liege, Belgium, 28 November 2023 – 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, will hold five presentations on the role of estrogens – including its estetrol (E4) – in a symposium at the European Society of Gynaecology Congress, which will take place from 29 November to 02 December in Amsterdam, The Netherlands.

A total of five abstracts will be presented referring to the beneficial effects of the combined oral contraceptive estetrol + drospirenone (E4 + DRSP) on blood pressure, patient-reported outcome measures in postmenopausal women from a phase-3 trial, and a look at E4 as a promising new candidate for menopausal vasomotor symptoms.

E4 is a key active pharmaceutical ingredient in both Mithra’s marketed contraceptive ESTELLE^®, and its next generation hormone therapy candidate for postmenopausal symptoms, DONESTA^®, with data from preclinical and clinical studies showcasing its promising safety and efficacy profile.

Dr. Graham Dixon, Chief Scientific Officer of Mithra, said, “We are excited that organizers of the ESG congress have taken such an active interest in the positive impact of estetrol. The abstract presentations at the congress will provide these leading experts with a unique opportunity to present the vital role of estrogens in women’s health, and the potential ground-breaking characteristics of our E4 product to support healthcare professionals and women’s confidence in hormone therapy. Current data strongly suggests that E4’s unique molecular mode of action and metabolism contribute notably to its selective pharmacological profile, suggesting its favorable benefit–risk ratio in transforming women’s health. We thank our presenters, who are all leading experts in this field, and we look forward to the many interesting discussions these abstracts will enable us to have at the ESG Congress”.

Mithra’s E4 demonstrates therapeutic efficacy beyond contraception as a component within a combined oral contraceptive with drospirenone and is currently under development for menopausal hormone therapy. It elicits estrogenic activity in uterovaginal tissues, contributing to bone turnover, and shows positive effects on cardiovascular functions. E4’s profile shows a low estrogenic impact on the liver and hemostasis balance, suggesting a diminished thrombotic risk.

The following abstracts will be presented at the ESG:

• Beneficial effects of the combined oral contraceptive estetrol/drospirenone (E4/DRSP) on blood pressure.
  • Authors: J.M. Foidart, Jonathan Douxfils , Mitchell D. Creinin, Kristina Gemzell Danielsson, Ali Kubba and Ulysse Gaspard
    • Saturday, 02 December, 9:45am
    • Speaker: Prof. Kristina Gemzell Danielsson
• Beneficial effects of the combined oral contraceptive estetrol/drospirenone (E4/DRSP) in participants with high normal baseline blood pressure.
  • Authors: J.M. Foidart, Jonathan Douxfils, Mitchell D. Creinin, Kristina Gemzell Danielsson, Ali Kubba and Ulysse Gaspard
    • Saturday, 02 December. 9:45am
    • Speaker: Prof. Ali Kubba
• Estetrol (E4):  A Promising New Treatment for the Spectrum of Menopausal Symptoms
  • Authors: Amanda Black, Jean Michel Foidart
    • Friday, 01 December, 15:30
    • Prof. Jean-Michel Foidart
• The Effect of Estetrol (E4) on Patient-Reported Outcome Measures in Postmenopausal Women – Results from a Phase 3 Trial
  • Authors: W.H. Utian, M. Taziaux, A. Black, U. Gaspard, R.A. Lobo and J.M. Foidart
    • Friday, 01 December, 15:30
    • Speaker: Mélanie Taziaux
• Estetrol (E4), a Promising New Treatment for Menopausal Vasomotor Symptoms: Beneficial Lipid and Carbohydrate Metabolism in a Phase 3 Randomized, Double-blind, Placebo-Controlled Trial
  • Authors: W.H. Utian, M. Taziaux, A. Black, U. Gaspard, R.A. Lobo and J.M. Foidart
    • Friday, 01 December, 15:30
    • Speaker: Prof. Ulysse Gaspard

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About Mithra

Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE^®, Mithra is now focusing on its second product DONESTA^®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com

ESTELLE^® and DONESTA^® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.

Important information

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes”, “estimates,” “anticipates”, “expects”, “intends”, “may”, “will”, “plans”, “continue”, “ongoing”, “potential”, “predict”, “project”, “target”, “seek” or “should”, and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

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