Brief: Hyloris Announces Start Of Phase 2 In Miconazole-Domiphen Bromide Study

Hyloris Pharmaceuticals SA

02/11/2021 11:18

Nov 2 (Reuters) - Hyloris Pharmaceuticals SA  HYL.BR :
    * HYLORIS ANNOUNCES START OF PHASE 2 STUDY OF
MICONAZOLE-DOMIPHEN
BROMIDE VAGINAL CREAM IN VULVOVAGINAL CANDIDIASIS
    * TOPLINE RESULTS ANTICIPATED IN H2 2022
    * PHASE 2 STUDY IS A MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND,
ACTIVE-CONTROLLED STUDY (3 STUDY ARMS), WHICH IS EXPECTED TO
ENROL UP TO 90 FEMALE SUBJECTS WITH CONFIRMED ACUTE VVC, AGED
18-50 YEARS
    * PRIMARY OBJECTIVES AT DAY 15 INCLUDE EFFICACY AND SAFETY
OF TWO
DIFFERENT DOSES OF MCZ NITRATE 2% + DB (MCZ-DB), ADMINISTERED
ONCE PER DAY FOR 7 DAYS
    * STUDY AIMS TO DETERMINE MOST OPTIMAL DOSE OF DB AFTER
7-DAY
TREATMENT OF VVC, BY ASSESSING EFFICACY AND SAFETY DURING 12
WEEKS OF FOLLOW-UP FROM START OF TREATMENT
    * STUDY WILL BE CONDUCTED IN AT LEAST 4 STUDY SITES, ALL
LOCATED
IN BELGIUM

Source text for Eikon:  ID:nGNX5fQDfN 
Further company coverage:  HYL.BR 

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