Mithra Announces Improved Consolidated Topline Results from Donesta® Phase 3 Studies and Launch of Recruitment for the Extension of European Study


• Consolidated analysis of Phase 3 topline data showed even more positive results than initially announced, with all four co-primary endpoints met
• Donesta® safety profile confirmed by independent Data Safety Monitoring Board (DSMB), which recommended to continue the Phase III Clinical Program
• Launch of the recruitment of the additional 300 menopausal women thanks to a successful mitigation plan

Liege, Belgium, 14 April 2022 – 7:30 CEST – 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.