Publication date: 08/06/2018
Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today presents its Phase IIb results for Donesta® at the International Menopause Society’s 16th World Congress on menopause (Vancouver, Canada).
Donesta® is Mithra’s next-generation hormone therapy (HT) product candidate with oral administration of Estetrol (E4) for the treatment of Vasomotor Symptoms (VMS), and in particular hot flushes relief, in post-menopausal women. Mithra recently announced positive top-line results, showing a significant improvement on the frequency and severity of hot flushes, as well as on secondary menopausal symptoms such as VVA, while indicating a beneficial safety profile.
The following key notes lectures will be presented at a dedicated Symposium titled Estetrol (E4) development update: a new horizon for post-menopausal women? :
Prof. Jean-Michel Foidart, MD, Perpetual Secretary of the Royal Academy of Medicine of Belgium: “The results of the Donesta® study are promising indeed. The 15 mg E4 dose significantly reduces the frequency and severity of hot flushes as well as bothersome secondary symptoms such as VVA. Moreover, the detailed statistical analyses further reinforce the robustness of the results.
The safety profile with regard to hemostatic and metabolic factors is very encouraging and coherent with the previous Phase II data findings in contraception (Estelle®). Both the Estelle® and Donesta® studies show that E4’s mixed agonist/antagonist estrogenic activity supports its distinctive profile and added clinical benefits.
Hence, we are fully aligned with our advisors and KOLs in the recommendation to pursue the development of Donesta®, and to move the product candidate into Phase III trials to further confirm these promising results. If approved, Donesta® may offer a next-generation hormonal therapy, with an improved benefit/risk profile, to women suffering from menopausal symptoms worldwide.”
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women's health, with a particular focus on fertility, contraception and menopause. Mithra's goal is to develop new and improved products that meet women's needs for better safety and convenience. Its two lead development candidates - a fifth generation oral contraceptive, Estelle®, and a next generation hormone therapy, Donesta® - are built on Mithra's unique native estrogen platform (E4). Mithra also develops and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its Mithra CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com