Liege, Belgium - Mithra (Euronext Brussels: MITRA), a company dedicated to Women's Health, today announces positive efficacy top-line results from Donesta Phase 3 pivotal 'E4 Comfort' clinical trials for the treatment of Vasomotor Symptoms (VMS) in post- menopausal women. Donesta is Mithra's next generation orally-administrated estetrol (E4)-based hormone therapy product candidate.

Launched in late 2019, the Phase 3 Clinical Program carried out in 2,300 postmenopausal women (40-65 years) includes 2 pivotal studies: one in North America (C302); and a second in 14 countries in Europe, Latam and Russia (C301). Both studies are worldwide randomized, multicentre, double-blind, placebo-controlled trials. This Phase 3 Program aims to measure the treatment effects of vasomotor symptoms' frequency and severity at 15mg and 20 mg doses of E4, especially for hot flushes. The co- primary efficacy endpoints are the mean change from baseline in the frequency and severity of moderate to severe VMS at week 4 and week 12 compared to placebo.

Both studies demonstrated a meaningful reduction in VMS frequency and severity from baseline and compared to placebo. At week 12, the results showed a reduction up to 80% in the frequency of hot flushes when compared to baseline. Regarding the severity, this reduction was up to 56% compared to baseline. All co-primary efficacy endpoints were statistically (all p

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