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SCYNEXIS (NASDAQ:SCYX) introduced on Thursday that the corporate’s Part 3 CANDLE examine for the fungicidal agent, ibrexafungerp, met the first and key secondary endpoints with statistical significance within the prevention of recurrent vulvovaginal candidiasis (rVVC), also referred to as vaginal yeast an infection.
The 260-patient examine was designed to evaluate the share of topics with medical success at 24 weeks as its major endpoint.
In keeping with 24-week knowledge, 65.4% of sufferers receiving ibrexafungerp achieved medical success in comparison with 53.1% of placebo-treated sufferers (p=0.02). The profit was discovered to be sustained over a three-month follow-up interval with statistical significance (p=0.034).
The corporate additionally offered knowledge from an extra 24 sufferers who failed to answer a three-day routine of antifungal treatment fluconazole. 71% of those that obtained a one-day open-label course of ibrexafungerp (300 mg BID) achieved a big discount or elimination of indicators and signs, SCYNEXIS (SCYX) mentioned.
Within the trial, the drug was usually protected and well-tolerated with no critical drug-related antagonistic occasions, and discontinuations resulting from antagonistic occasions.
A supplemental New Drug Utility (sNDA) for BREXAFEMME for the prevention of rVVC is deliberate for H1 2022, with approval anticipated later this 12 months.
A convention name on examine outcomes is scheduled for as we speak at 8:30 a.m. ET.
In Sep. 2021, SCYNEXIS (SCYX) introduced the U.S. launch of Brexafemme (ibrexafungerp tablets) to deal with vulvovaginal candidiasis.
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