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ARTICLE | Clinical News

Scynexis planning Phase III program for vulvovaginal candidiasis candidate

July 20, 2018 5:46 PM UTC

Scynexis Inc. (NASDAQ:SCYX) said all five dose regimens of oral SCY-078 showed "meaningful clinical and mycological activity" in the double-blind, U.S. Phase IIb DOVE trial in 186 patients with moderate to severe acute vulvovaginal candidiasis. Next quarter, the company plans to start a Phase III program evaluating the optimal dose regimen of twice-daily 300 mg SCY-078 to treat acute and recurrent vulvovaginal candidiasis.

In the culture-confirmed modified intent-to-treat (ITT) population of DOVE (n=153), 52% (14/27) of patients who received twice-daily 300 mg SCY-078 for one day achieved clinical cure, defined as complete resolution of all signs and symptoms, at the test-of-cure (TOC) visit at day 10 vs. 58% (14/24) of patients who received standard of care (SOC) fluconazole. At the day 25 follow-up visit, the clinical cure rate was 70% in the twice-daily 300 mg SCY-078 arm vs. 50% for fluconazole. Scynexis said the trial was not powered to show significant differences on any endpoint...

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Beta 1,3-D-glucan synthase