SCY-078, if approved, may represent an optimal therapy for the treatment of acute vulvovaginal candidiasis (VVC) and for prevention of recurrence. SCY-078 is orally administered and is extensively distributed into vaginal tissues. It is also fungicidal, with a broad spectrum of activity and enhanced activity in the acidic pH at the site of infection.
Acute VVC and recurrent VVC are serious conditions with significant morbidity and with very limited oral treatment options. No product is approved for the prevention of recurrent VVC, and current treatment alternatives have significant limitations, particularly in patients with other comorbidities and those who are taking certain concomitant medications, are pregnant or are experiencing episodes caused by an azole-resistant micro-organism.
VVC, commonly known as a "vaginal yeast infection," is the second most common cause of vaginitis and is usually caused by Candida spp. It affects approximately 70-75% of women at least once in their lifetime, with 40-50% of these women experiencing more than one episode. The majority of VVC episodes are uncomplicated cases with sporadic mild-to-moderate infections. The remaining complicated cases are severe and/or recurring infections.
VVC can be associated with substantial morbidity, including significant genital discomfort, reduced sexual pleasure, psychological distress and loss of productivity. Diagnosis and treatment, combined with lost productivity, are estimated to cost $1.0 billion per year in the U.S. Current treatments for VVC include over-the-counter (OTC) topical azole antifungals and the prescription oral azole antifungal, fluconazole.
*Data on File (2015 IMS Consulting Group study, commissioned by SCYNEXIS).
SCY-078 could provide a first-line therapy for recurrent VVC, for which there is currently no FDA-approved treatment, and be the only oral, non-azole, fungicidal treatment for moderate and severe cases of VVC.
- Dr. Jack D. Sobel
Current Infectious Disease Reports 2006,8:481–486
Clinical experience to date has shown promising evidence of the antifungal activity of SCY-078 in patients with Candida infections.
(ClinicalTrials.gov Identifier: NCT02679456)
The DOVE study is a randomized, multicenter, double-blind, active-controlled, dose-finding study designed to identify a safe and efficacious dose regimen of oral SCY-078 in adult female patients. Approximately 180 patients with moderate to severe acute VVC were randomized to one of five different regimens of oral SCY-078 or oral fluconazole, the current standard of care (SoC). 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. Mycological eradication (negative fungal culture) will also be evaluated at the same time points. Enrollment in the trial was recently completed, and SCYNEXIS expects top-line results by July 2018.
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SCYNEXIS anticipates that the dose regimen selected from the DOVE study will be subsequently evaluated in Phase 3 studies following an End-of-Phase 2 meeting with the FDA. SCYNEXIS expects to initiate the Phase 3 clinical program in the fourth quarter of 2018 and file a New Drug Application (NDA) for acute VVC in 2020.
Preliminary assessment (to be further validated). SCYNEXIS Primary HCPs and Payers Market Research.
CDC: Vaginal Candidiasis.
