Liege, Belgium - Mithra (Euronext Brussels: MITRA), a company dedicated to Women's Health announces topline results of the Coronesta Phase II study, which aimed to assess the safety and efficacy of estetrol (E4) for the treatment of patients who were hospitalized with moderate COVID-19. E4 is a native occurring estrogen produced by the human fetus during pregnancy.

Phase II Design

The Phase II Study1 was an international, multi-center study that evaluated the safety and efficacy of estetrol (E4) 15 mg tablet, relative to placebo, in 175 patients (male/female) hospitalized with moderate COVID-19 (i.e., not on high flow oxygen or mechanical ventilation). Patients were randomly assigned to receive either E4 or identical placebo for 21 days. All patients received anticoagulant therapy as part of standard-of-care for COVID-19 for 21 days. The clinical program included centers in Belgium, Russia, and Poland. The primary assessment of the study was the ability of E4 to increase the percentage of patients hospitalized with moderate COVID-19 that recover within 28 days compared with placebo. The secondary assessments included evaluation of safety (including markers of potential blood clotting), and measurements of disease worsening, time to recovery and viral load. Exploratory biochemical markers of inflammation and other measures of disease progress were also collected. This is the first prospective clinical trial of an estrogen to report results in COVID-19.

Contact:

Benoit Mathieu

IRO

T: +32 473 35 80 18

E: investorrelations@mithra.com

Press

Maud Vanderthommen

T: +32 473 58 61 04

E: press@mithra.com

About Mithra

Mithra (Euronext: MITRA) is a Belgian biotech 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. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liege, Belgium. www.mithra.com

(C) 2021 Electronic News Publishing, source ENP Newswire