Mithra, a company dedicated to Women’s Health, announces that its independent Data and Safety Monitoring Board (DSMB) completed its end-of-year safety assessment of the Phase III Clinical Program of Donesta®, a next generation orally-administered E4-based hormone therapy product candidate for the relief of menopausal vasomotor symptoms (VMS).
The independent board of experts confirmed an expected pharmacological profile during the trial from initiation until the safety evaluation of 1.369 patients treated, and recommended to continue the studies without modification. As per study protocol, the DSMB meets quarterly to review the safety data of the Phase III Donesta® Study and issues recommendations on the conduct of the study.
Graham Dixon, CSO Mithra Women’s Health, commented: “This positive recommendation from our independent board of experts confirms the safety profile of Estetrol in addition to the data already obtained on Estelle® contraceptive. Since the beginning of the Covid pandemic, we have put in place a safety management plan for our active sites and have made every effort to ensure patient safety, trial integrity and good progress of the studies in the different regions. The conclusion of the DSMB allows us to continue our clinical program as planned, with results expected in the first half of 2022. We remain confident in the promising potential of Donesta® as a next generation alternative addressing the unmet needs of menopausal women.”
Launched in late 2019, the Donesta® Phase III clinical program called "E4 Comfort" aims to recruit approximately 2,200 postmenopausal women (40-65 years) and includes two pivotal studies: one in North America (United States/Canada); one in 14 countries in Europe, Russia and America. Both studies are worldwide randomized, multicenter, double-blind, placebo-controlled 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.
Depending on the evolution of the Covid-19 situation and regulatory approvals, Mithra believes it could achieve marketing authorization for Donesta® in 2023. Thanks to the recent consolidation of Mithra’s Estetrol patent portfolio, Donesta® is protected until 2036 in Europe, with a similar patent application filed in the United States.
Furthermore, major funding transactions in 2020 for a total of EUR 260 million reinforces Mithra's business development strategy for Donesta®, targeting major global partners in women's health while generating more data in the Phase III trial. The global menopause market currently stands at nearly USD 13 billion, which is expected to grow to approximately USD 16 billion by 2025