SCYNEXIS (SCYX)

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SCYNEXIS Announces Initiation of Dosing in Phase 2 Study Evaluating Oral SCY-078 in Vulvovaginal Candidiasis

GlobeNewswire•August 3, 2017

Study initiation marks important milestone following promising clinical results in previous Phase 2 study

Additional pre-clinical results for VVC to be presented at upcoming 2017 IDSOG Annual Meeting

JERSEY CITY, N.J., Aug. 03, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced the first patient has been dosed in a Phase 2 study of oral SCY-078 for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. SCY-078 would potentially be the first oral and intravenous (IV) representative of a novel triterpenoid antifungal family with fungicidal activity against Candida. Top-line results from this study are expected in mid-2018.

“SCY-078 demonstrated the potential to provide high clinical cure rates (78% vs. 66% for fluconazole) for women suffering from VVC in the proof-of-concept Phase 2 study we completed last year, making it the first novel triterpenoid antifungal agent with fungicidal activity for women with VVC,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “We were also encouraged by the four-month follow-up data that showed a lower recurrence rate (4% vs. 15% for fluconazole), indicating the potential of SCY-078 to become an important treatment option for patients suffering from recurrent VVC, where the unmet need is significant.”

“In multiple clinical studies, SCY-078 has demonstrated a broad spectrum of activity across a range of Candida isolates, supporting the potential clinical utility of SCY-078 against a number of life-threatening and mucocutaneous infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe SCY-078’s key attributes, such as fungicidal activity against Candida and high-tissue penetration, can be major differentiators in treating VVC infections and preventing recurrence. The commencement of this Phase 2 study is another important step in proving the flexibility of use and potential clinical benefits of this novel product against fungal infections, including multidrug-resistant strains.”

About the DOVE Study
The Phase 2 clinical trial is a randomized, multicenter, double-blind, active-controlled, dose-finding study designed to evaluate the safety and efficacy of oral SCY-078 vs. oral fluconazole in adult female patients. Approximately 180 patients with moderate to severe acute VVC will be randomized to one of five different regimens of SCY-078 or oral fluconazole, the current standard of care. The study will assess the efficacy, safety, tolerability and pharmacokinetics of SCY-078. Efficacy will be measured by the percentage of patients with clinical cure (complete resolution of signs and symptoms) at the test-of-cure visit at day 10 (primary endpoint) and at a follow-up visit on day 25. Other efficacy assessments will include mycological eradication (negative fungal culture) at the same time points.

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