Mithra Receives Positive DSMB Opinion on DONESTA European Phase 3 Trial

Mithra Receives Positive DSMB Opinion on DONESTA European Phase 3 Trial

• The DSMB recommends continuing the phase 3 trial in Europe following regular safety assessment
• The menopause phase 3 program has previously reported positive top-line data; extension to Europe trial ongoing
• Additional endometrial data analyses ongoing for inclusion in regulatory submissions
• Mithra plans to submit DONESTA for approval by U.S. and European regulators in Q4 2024

Liege, Belgium, 18 December 2023 – 7:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces it has received a positive review from the independent Data and Safety Monitoring Board (DSMB) on its phase 3 program for DONESTA, its investigational, next generation hormone therapy medicine containing estetrol (E4) for the treatment of the symptoms of menopause.

All clinical investigations involving greater than minimal risk to participants are, at a minimum, required to develop a data and safety monitoring plan to assure the safety and welfare of the participants. The DSMB experts completed their latest regular safety assessment of the randomized, multicentred and double-blind phase 3 trial of DONESTA in Europe (C301), which has recruited 300 additional menopausal non-hysterectomised women, and recommended to continue the study extension. The last patient-out is expected in Q1 2024. Positive efficacy top line results have been previously reported from the menopause phase 3 program, including the European trial. Top level safety conclusions were reported as well from the US trial (C302). Mithra plans to submit DONESTA for the treatment on menopause symptoms for approval by regulators in the U.S. and Europe in Q4 2024.

Graham Dixon, Chief Scientific Officer of Mithra, commented, “This DSMB recommendation allows us to continue the extension of the DONESTA phase 3 trial in Europe, which will generate important data for our marketing authorization applications. The role of the DSMB is to review the safety profile of a treatment during the clinical study, and to independently safeguard the interests of study participants. The DSMB review general safety data and endometrial safety data across the studies at regular, pre-defined intervals while the clinical studies are ongoing. The DSMB’s decision is a testament to the safety of DONESTA— our next generation orally administrated E4-based hormone therapy product candidate— which offers a potential long-term solution for treating various symptoms of menopause.”