A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis
Open accessAbstract
BACKGROUND: Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC. METHODS: Participants presenting with an acute episode of VVC (n = 55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to receive a single dose of fluconazole 150 mg (FDA-approved dose to treat acute VVC). Participants were followed for 6 months. The primary outcome was the proportion of participants with therapeutic (clinical and mycological) cure at day 28. RESULTS: A larger proportion of participants in the per-protocol population experienced therapeutic cure in the VT-1161 300 mg q.d. (75.0%), VT-1161 600 mg q.d. (85.7%), and VT-1161 600 mg b.i.d. (78.6%) groups vs the fluconazole group (62.5%); differences were not statistically significant. At 3 and 6 months, no participants in the VT-1161 groups vs 28.5% and 46.1% in the fluconazole group, respectively, had evidence of mycological recurrence. No serious adverse events or treatment-emergent adverse events leading to discontinuation were reported. CONCLUSIONS: The majority of participants across all treatment groups achieved therapeutic cure at day 28. VT-1161 was well tolerated at all dose levels through 6 months of follow-up. CLINICAL TRIALS REGISTRATION: NCT01891331.
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The MIC of oteseconazole against fluconazole-resistant C. glabrata was 64-fold lower than the MIC of fluconazole.
“The minimal inhibitory concentration (MIC) of oteseconazole against fluconazole-resistant C. glabrata was 64-fold lower than the MIC of fluconazole [55].”
From Treatment of Vulvovaginal Candidiasis—An Overview of Guidelines and the Latest Treatment Methods (2023) · cites this paper as [55]
In a phase IIa study of 55 participants, there was no statistical difference between oteseconazole and fluconazole.
“A phase IIa study by Brand et al., conducted on 55 participants, comparing oteseconazole to fluconazole showed no statistical difference between the groups treated with these drugs.”
From Treatment of Vulvovaginal Candidiasis—An Overview of Guidelines and the Latest Treatment Methods (2023) · cites this paper as [55]
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- Authors
- Brand, S. R., Sobel, J. D., Nyirjesy, P., Ghannoum, M. A., Schotzinger, R. J., & Degenhardt, T. P.
- Affiliations
- Viamet Pharmaceuticals (United States) (US)
- Wayne State University (US)
- Thomas Jefferson University (US)
- University Hospitals of Cleveland (US)
- Corresponding author
- Brand, Stephen R
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-08-20
- Volume
- 73
- Issue
- 7
- Pages
- e1518-e1524
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC8492116
- OpenAlex
- W3080884461
- Cited by
- 61
- References
- 19
- Citations by year
- 2026: 5 · 2025: 7 · 2024: 8 · 2023: 15 · 2022: 17 · 2021: 9
- FWCI
- 1.34
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Infectious Diseases (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- The Medicine Forum (submittedVersion, cc-by-nc-nd)
- Funders
- Viamet Pharmaceuticals, Inc.
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Life Sciences › Agricultural and Biological Sciences › Ecology, Evolution, Behavior and Systematics › Fungal Plant Pathogen Control
- Keywords
- vaginal candidiasis, oteseconazole, fluconazole, CYP51 inhibitors, antifungal treatment efficacy, treatment safety, oral antifungal agents
- MeSH terms
- Administration, Oral, Antifungal Agents, Candidiasis, Vulvovaginal, Female, Humans, Pyridines, Tetrazoles, Fluconazole
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