Publication date: 31/12/2019
Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the recruitment of the first patient for the second pivotal Phase III Donesta® clinical study. Donesta® is a next generation orally-administered E4-based hormone therapy product candidate for the relief of menopausal vasomotor symptoms (VMS).
The Donesta® Phase III study program called “E4 Comfort” includes two pivotal studies: in North America (United States/Canada) launched in October 20191, and in Europe, Russia and South America, which just began. E4 Comfort are worldwide randomized, multicenter, double-blind, placebocontrolled trials. The studies’ primary objective is to measure the effect of treatment on frequency and severity of moderate to severe VMS (i.e. hot flushes), with different doses of E4 (15mg and 20 mg), in menopausal women at 4 and 12 weeks of treatment. Secondary objectives include the evaluation of the effect of the treatment on a series of additional key efficacy and safety parameters.
The North American study (United States/Canada) is aimed at enrolling approximately 1000 menopausal women between 40 and 65 years. The second pivotal study (Europe/Russia/South America) will be conducted with about 1200 menopausal women. For each pivotal study, women will be recruited at about 120 sites in the concerned areas. The Phase III Program, entirely funded by Mithra, should be completed over a period of two years.
Depending on the study results and regulatory approvals, Mithra believes that marketing authorization for Donesta® could be granted in 2023. Ongoing patent applications would protect Donesta® intellectual property rights until 2039. Furthermore, Mithra remains focused on establishing the best commercial partnerships for this product. The global menopause market currently stands at USD 12.6 billion and is expected to grow to approximately USD 16 billion by 20252.
For more information about the E4 Comfort Phase III program, please visit www.clinicaltrials.gov (North American study online NCT04090957 - Europe/Russia/South America study available in the coming weeks).
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women’s Health, with a particular focus on contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its three lead development candidates – a fifth generation oral contraceptive Estelle®, the first complete oral treatment for perimenopause PeriNesta™ and next-generation hormone therapy Donesta® - are built on Mithra’s unique native estrogen platform, E4 (Estetrol). Mithra also develops and manufactures complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at www.mithra.com