Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today 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.
Successful recruitment of 1015 menopausal women for Donesta® Phase III US/Canada pivotal study
Recruitment of additional patients for Donesta® Phase III Europe/Latam, mostly due to Covid19, with a completion anticipated by H1 2022
Primary efficacy data of both studies anticipated for end 2021
Independent Data Safety Monitoring Board (DSMB) confirmed the safety profile of Donesta®
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 placebo (1). 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. This consolidated analysis showed that all co-primary efficacy endpoints (2) were statistically (all p<0.05) met in both studies. Even in the C302 study, the result for the severity criteria reached statistical significance at week 4, and not at week 5 as initially reported.
Launch of Recruitment for Extension European Study
Mithra also announces today the initiation of the recruitment of 300 additional menopausal nonhysterectomised women for its Donesta® European Study (C301), following the decision of the independent Data and Safety Monitoring Board (DSMB). The experts of the DSMB completed the first 2022 quartely safety assessment of the Phase 3 Clinical Program of Donesta® and recommended to continue the studies, allowing Mithra to launch the recruitment for the extension of the European study (3). Thanks to the implementation of our mitigation plan activated immediately after the beginning of the geopolitical crisis in Eastern Europe, all the Russian sites originally selected for participating in the study were replaced by other sites to ensure a direct start of recruitment. The recruitment of these 300 women should be completed within the next 6 months. Barring any unforeseen event, Mithra confirms its ambition to achieve marketing authorization for Donesta® in H1 2024 for the United States and in H2 2024 for Europe. The Donesta® Phase III Clinical Program is still ongoing with patients completing a treatment duration for 52 weeks. The primary safety data are anticipated at the end 2022 for the North American study (C302) and for end H2 2023 for the European study (C301).
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.”