Mithra Announces Positive Donesta® Phase IIb Study Achieving Primary Objective and Confirming Promising Safety Profile

  • E4 Relief dose-finding study identifies 15 mg E4 as the optimal minimum dose for effective treatment of VMS (hot flushes)
  • 15 mg E4 demonstrated a meaningful reduction of over 80% in VMS versus baseline, and a statistically significant reduction compared to placebo
  • Safety profile consistent with previous E4 studies confirming Donesta®’s promising hemostatic and lipid profile, as well as an improved quality of life
  • Data strongly support further development of Donesta® as a unique next-generation hormone therapy

Liège, Belgium, 19 April 2018 – 7:30 AM – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces positive topline results from the E4 Relief Phase II study of Donesta® for the treatment of Vasomotor Symptoms (VMS), and in particular hot flushes relief, in post-menopausal women, with the study achieving its primary and key secondary objectives. Donesta® is Mithra’s next-generation hormone therapy (HT) candidate with oral administration of Estetrol (E4).