MITHRA ANNOUNCES COMPLETION OF RECRUITMENT IN DONESTA® PHASE II STUDY
* Donesta® Phase II study remains on track to report top line data late Q1 2018
* 260 women recruited in total, of which 86 have already completed at least 12 weeks of treatment as part of the Phase II study
Liège, Belgium, 13 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the completion of recruitment in the E4 Relief Phase II study of Donesta®, Mithra’s next-generation hormone therapy (HT) candidate with oral administration of Estetrol (E4) for Vasomotor Menopausal Symptoms (VMS) relief.
Top-line data, based on 12-weeks of treatment, remain on track to be reported late in the first quarter of 2018. The E4 Relief dose-finding study includes centres in the Czech Republic, Poland, Belgium, the Netherlands, Ireland and the UK, with subjects receiving Donesta® for a treatment period of 12 weeks.
The primary objective of the Phase II clinical trial is to identify the oral daily minimum dose of Donesta® required to effectively treat VMS, or hot flushes, in post-menopausal women. In total four dose levels of Donesta® are being tested compared to placebo in this double-blinded study. Secondary outcomes include an evaluation of other menopausal symptoms such as vulvo-vaginal atrophy (VVA), or vaginal dryness, lipid and glucose metabolism as well as bone metabolism markers. The study will also analyze key safety issues including endometrial thickness. Research shows that current HT-based treatments may increase the risk of breast cancer and venous thromboembolic events (VTE) such as blood clots. Thanks to the unique mode of action of the native estrogen E4, Donesta® has the potential to offer an improved safety profile, addressing the unmet medical need in menopause.
Interessant om te lezen dat de resultaten van deze studie nog steeds worden verwacht in (late) Q1 volgend jaar. Ik kan me niet voorstellen dat ze dat gaan halen. Persoonlijk verwacht ik de resultaten in Q2 2018!