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Scynexis Presents P-III (CANDLE) Study Results of Ibrexafungerp for the Prevention of Recurrent Vaginal Yeast Infections at IDSOG 2022

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Scynexis Presents P-III (CANDLE) Study Results of Ibrexafungerp for the Prevention of Recurrent Vaginal Yeast Infections at IDSOG 2022

Scynexis Presents P-III (CANDLE) Study Results of Ibrexafungerp for the Prevention of Recurrent Vaginal Yeast Infections at IDSOG 2022

Shots:

  • The P-III (CANDLE) study evaluating ibrexafungerp (300mg, BID) vs PBO in 260 female patients with RVVC. Patients initially received a 3-day regimen of fluconazole
  • The trial met its 1EPs i.e., 65.4% vs 53.1% of patients achieved clinical success with no recurrence at all either culture-proven, presumed, or suspected who received monthly single-day ibrexafungerp @24wks., superiority over PBO in 1EPs & 2EPs incl. no mycologically proven recurrence in 70.8%
  • In ITT & mITT population, 71% & 80% achieved a reduction or elimination of signs & symptoms, were safe & well-tolerated with no serious drug-related AEs, and no patients discontinued therapy due to AEs. The US FDA will review the sNDA of Brexafemme for an additional indication to prevent RVCC on Nov 30, 2022

Ref: SCYNEXIS | Image: SCYNEXIS

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Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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