Brief: Mithra: Positive Top-Line Results From Donesta Phase 3 Studies In Menopausal Women

Mithra Pharmaceuticals SA

14/01/2022 06:38

Jan 14 (Reuters) - Mithra Pharmaceuticals SA  MITRA.BR :
    * ANNOUNCES POSITIVE TOP-LINE RESULTS FROM DONESTA PHASE 3
STUDIES
IN MENOPAUSAL WOMEN
    * POSITIVE EFFICACY DATA STRONGLY MOVE FORWARD CLINICAL
PROGRAM,
RECENTLY EXTENDED WITH 3 ADDITIONAL STUDIES TO FURTHER BROADEN
SCOPE OF DONESTA AS A GLOBAL ALTERNATIVE FOR MILLIONS OF
MENOPAUSAL WOMEN
    * PRIMARY SAFETY RESULTS ANTICIPATED FOR END 2022 IN UNITED
STATES/CANADA AND FOR END H1 2023 IN EUROPE
    * ON TRACK TO TARGET MARKETING AUTHORIZATION IN 2024
    * DONESTA SAFETY PROFILE CONFIRMED BY END-YEAR INDEPENDENT
DATA
SAFETY MONITORING BOARD (DSMB), WHICH RECOMMENDED TO CONTINUE
PHASE III CLINICAL PROGRAM AS PLANNED
    * BOTH STUDIES DEMONSTRATED A MEANINGFUL REDUCTION IN VMS
FREQUENCY AND SEVERITY FROM BASELINE AND COMPARED TO PLACEBO
    * FOR C302 STUDY, RESULTS FOR SECONDARY ENDPOINTS AT 3 AND
12
MONTHS ARE EXPECTED END 2022
    * MITHRA BELIEVES IT COULD ACHIEVE MARKETING AUTHORIZATION
FOR
DONESTA® IN H1 2024 FOR THE UNITED STATES AND IN H2 2024 FOR
EUROPE
    * THREE ADDITIONAL STUDIES ON THE EFFECT OF E4 ON
VULVOVAGINAL
ATROPHY, SKIN AND HAIR QUALITY WILL BE LAUNCHED IN 2022,
DEPENDING ON REGULATORY AGENCY FEEDBACK
    * THE DONESTA PHASE III CLINICAL PROGRAM: PRIMARY SAFETY
DATA ARE
ANTICIPATED AT THE END 2022 FOR THE AMERICAN STUDY AND FOR END
H1 2023 FOR THE EUROPEAN STUDY

Source text: https://bit.ly/3flng8L
Further company coverage:  MITRA.BR 

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