Evaluation of Arasertaconazole Nitrate Efficacy in a Vaginal Candidiasis Rat Model

Ref ID: 18803

Author:

F. Cabello, DVM – Researcher, N. Marti, PhD – Drug Development Project Leader, D. Gargallo-Viola, PhD – Infectious Diseases Manager, A. Guglietta, PhD – R&D Director;

Author address:

Res. and Dev. Ctr.. Ferrer Internacional SA, Barcelona, Spain

Full conference title:

52nd Annual ICAAC

Date: 9 September 2014

Abstract:

Background: Arasertaconazole nitrate is a new topical anti8209;mycotic molecule which has shown a wide spectrum of activity against yeasts, dermatophytes, moulds and clinically relevant bacterial. In this study, the in vivo therapeutic efficacy of arasertaconazole nitrate vaginal ovule was evaluated against an experimental vaginal infection model with Candida albicans. Methods: Ovariectomized and oestrus-induced rats were immunosuppressed with dexamethasone in the drinking water. Vaginal candidiasis was established by intravaginal inoculation of 107CFU of C.albicans ATCC44858. Rats (n = 5 per group) received a 3 days repeated intravaginal administration using a ovule with a fixed volume of 0.1 ml. Animals were administered once a day with Placebo, 6.25% or 25% of arasertaconazole nitrate. Antifungal efficacy was assessed by colony counts obtained from vaginal smears and by histological examination 24 h after last dose. Results: Animals treated with 6.25 % or 25% of Arasertaconazole nitrate showed marked therapeutic efficacy 24 h after the last dose. A good dose-response was observed with a fungal burden reduction (Mean ± SD log CFU/mL sample) of 2.61 ± 0.40 in 6.25% group and 3.32 ± 1.15 in 25% group. A good correlation between histological results and microbiological results was observed. No relevant fungal presence was detected in histological samples taken from 6.25 % or 25 % treated animals. Conclusion: Arasertaconazole nitrate has demonstrated a strong in vivo efficacy against C.albicans.

Abstract Number: M-980

Conference Year: 2012

Link to conference website: NULL

New link: NULL

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