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Cited by 42Nail Diseases and TreatmentsAntifungal resistance and susceptibilityFungal Infections and Studies

A phase II, randomized, double‐blind, placebo‐controlled, dose‐ranging study to evaluate the efficacy and safety of VT‐1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail*

Elewski, B., Brand, S., Degenhardt, T., Curelop, S., Pollak, R., Schotzinger, R., Tavakkol, A., Alonso‐Llamazares, Javier +25 more·2021·British Journal of Dermatology
DOI 10.1111/bjd.19224
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Abstract

BACKGROUND: Onychomycosis is a fungal disease that affects the fingernails and toenails and is predominantly caused by dermatophytes. VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of lanosterol demethylase, and has demonstrated potent activity against Trichophyton rubrum and Trichophyton mentagrophytes. OBJECTIVES: To evaluate the safety and efficacy of four dosing regimens of orally administered VT-1161 compared with placebo in patients with moderate-to-severe distal and lateral subungual onychomycosis of the toenail. METHODS: This was a phase II, randomized, double-blind, placebo-controlled, multicentre study (ClinicalTrials.gov identifier NCT02267356). Patients aged 18-70 years (n = 259) who had 25-75% mycotic involvement were randomized to five treatment groups. They received 300 mg VT-1161 as a 2-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks, or 600 mg VT-1161 as a 2-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks. All treatments were followed by a nontreatment period of 36 weeks. A matching placebo arm was included. RESULTS: In the intent-to-treat population, at week 48 the complete cure rates were 0% in the placebo group and ranged from 32% to 42% in the VT-1161 treatment groups (P < 0·001 vs. placebo). VT-1161 was well tolerated, with no evidence of an adverse effect on liver function or QT intervals. CONCLUSIONS: VT-1161 treatment led to high nail clearance rates and a favourable safety profile. VT-1161 exhibits characteristics that appear promising for the treatment of this chronic and difficult-to-treat condition and warrants further evaluation in larger studies.

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Crossref · 10.1111/bjd.19224

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  • VT-1161 is expected to be used for recurrent vulvovaginal candidiasis and onychomycosis.

    “while VT-1161 is poised to treat recurrent VVC and onychomycosis with potential to garner other indications as clinical development progress.”

    From Investigational Agents for the Treatment of Resistant Yeasts and Molds (2021) · cites this paper as [47]

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Authors
Elewski, B., Brand, S., Degenhardt, T., Curelop, S., Pollak, R., Schotzinger, R., Tavakkol, A., Alonso‐Llamazares, J., Ashton, S. J., Bhatia, N., Billings, M., Blauvelt, A., Bystol, N., Dodson, B., Gold, M. H., Grande, K., Jarratt, M., Jones, T. S., Kasper, M. A., Kempers, S. E., McConnehey, B., Noss, M., Pariser, D., Parish, L., Rich, P., Ahmad Samady, J., Schlessinger, J., Schumacher, D., Stein, K., Strout, C., Tschen, E., Tu, J. H., & Weisfeld, M.
Affiliations
  • University of Alabama at Birmingham (US)
  • Viamet Pharmaceuticals (United States) (US)
  • Endeavor Clinical Trials San Antonio TX USA
  • Moberg Pharma (Sweden) (SE)
Corresponding author
Brand, S.
ORCID
Venue
British Journal of Dermatology
Publisher
Oxford University Press (OUP)
Published
2020-07-13
Volume
184
Issue
2
Pages
270-280
ISSN
  • 0007-0963 (ISSN-L)
  • 1365-2133
DOI
10.1111/bjd.19224
OpenAlex
W3026274121
Cited by
42
References
22
Citations by year
2026: 6 · 2025: 2 · 2024: 6 · 2023: 4 · 2022: 9 · 2021: 14 · 2020: 1
FWCI
5.20
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • British Journal of Dermatology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Nail Diseases and Treatments
  • Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
  • Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
Keywords
subungual onychomycosis, toenail fungal infection, CYP51 inhibitors, Trichophyton rubrum, Trichophyton mentagrophytes, dose-ranging, oral antifungal therapy, drug safety
MeSH terms
Adolescent, Adult, Aged, Antifungal Agents, Arthrodermataceae, Double-Blind Method, Foot Dermatoses, Humans, Middle Aged, Nails, Pyridines, Tablets, Tetrazoles, Onychomycosis, Treatment Outcome, Young Adult

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