Recurrent vulvovaginal candidiasis (RVVC) is defined as the occurrence of three or more episodes of acute vulvovaginal candidiasis within a 12-month period. The infection involves the vaginal mucosa as well as the surrounding areas. It is estimated that RVVC afflicts 5 - 8% of women of child-bearing age in the United States. RVVC can be a source of significant discomfort, and leads to loss of work time, estimated at approximately 33 hours per year for a typical patient. RVVC is ranked by patients above migraine and similar to asthma and chronic obstructive pulmonary disease with regard to its negative impact on quality of life. While risk factors for RVVC are generally not well understood, diabetic patients are particularly prone to this condition. Despite the high prevalence of this condition, we believe that there are currently no agents in the U.S. approved to treat RVVC.
Acute vulvovaginal candidiasis is caused by various Candida species, the most common of which is Candida albicans. Candida glabrata and Candida tropicalis are also common causative agents. Unlike Candida albicans, which usually responds to topical agents or oral fluconazole, Candida glabrata and Candida tropicalis are often more resistant to these agents.
Treatment of acute vulvovaginal candidiasis typically consists of a topical antifungal agent or oral fluconazole to treat the acute infection, which may provide symptomatic relief for a few weeks to months. However, in the setting of RVVC, the infection continues to recur over time. For some patients with RVVC, chronic treatment with fluconazole given once-weekly may be utilized, even though fluconazole is not approved in the United States for this indication. However, there is significant concern regarding the chronic use of fluconazole in women of child-bearing age as a result of the drug’s Category D pregnancy warning and other safety issues. A clinical study of once-weekly fluconazole in RVVC published in the New England Journal of Medicine in 2004 demonstrated that approximately 91% of women were recurrence-free after six months of treatment. However, following the six-month treatment period only approximately 43% of women remained infection-free at 12 months. We believe that this high rate of relapse is due to the relatively low potency and short half-life of fluconazole.
Viamet is developing oral VT-1161 for the treatment of RVVC. This investigational agent has successfully completed a Phase 2b clinical study in patients diagnosed with RVVC. VT-1161 has the potential to be a safe and effective oral treatment for RVVC.