Liege, Belgium - Mithra (Euronext Brussels: MITRA), a company dedicated to Women's Health announces consolidated positive topline results of Phase 3 Donesta Program. Donesta is Mithra's next generation orally-administrated estetrol (E4)-based hormone therapy product candidate offering a potential long-term solution for treating different symptoms of menopause, simultaneously or sequentially, caused by estrogen loss.
All four co-primary endpoints met
On 14 January 2022, Mithra announced the first efficacy data of Donesta Phase 3 Program, which demonstrated a meaningful reduction in vasomotor symptoms (VSM) from baseline and compared to placebo1 . After further in-depth analysis of all the research data consolidated by the Contract Research Organization in charge of the management of the Donesta studies, Mithra is particularly pleased to announce that the efficacy results are even better than previously announced.
Leon Van Rompay, CEO Mithra Women's Health, commented: 'These excellent efficacy results demonstrates that Donesta should offer the most complete profile of symptom relief compared to any of the existing or pipeline therapies for menopause symptom treatment. By the end of the year we will be able to demonstrate again the unique safety profile of E4, building further on the fantastic potential of this molecule. From the very beginning of the geopolitical crisis, our teams have immediately activated a mitigation plan allowing us to launch the recruitment of the additional European study right after the DSMB's green light. Despite the current economical and geopolitical context, we don't expect any delay for the obtention of the marketing authorizations, which demonstrates that Mithra's teams remain fully focused on our achievements and strongly committed to converting the potential of our products into success.'
Benoit Mathieu (IRO) : +32 473 35 80 18 - investorrelations@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. 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 develops and manufactures complex therapeutics in the areas of contraception, menopause and hormonedependent 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
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MITHRA PHARMACEUTICALS S.A. 
