Mycovia Pharmaceuticals has commenced two Phase lll clinical trials called VIOLET to investigate the safety and efficacy of VT1161 for the treatment of patients with recurrent vulvovaginal candidiasis (RVVC).
Both the multi-centre, randomised, double-blind, placebo-controlled trials will be carried out in North America, Europe and Japan.
Each of the trials is expected to enrol 300 patients across approximately 60 sites across the globe.
The primary endpoint of both trials is the percentage of subjects with one or more culture-verified acute VVC episodes during the maintenance phase over a period of 48 weeks.
The VIOLET trial is expected to be completed by the second half of 2020, with plans for regulatory submissions in the US, European Union and Japan.
Mycovia Pharmaceuticals CEO Patrick Jordan said: “Women’s health is an underserved therapeutic area with significant unmet need. There are currently no approved treatment options for RVVC in the US today, despite the negative effects that the condition has on millions of women.
“We founded Mycovia to continue studying the candidate as a potential treatment option while also exploring its effectiveness in additional fungal infections such as onychomycosis.”
RVVC, also known as yeast infections, is estimated to affect around 5%-8% of women.
Its physical symptoms are itching, irritation, soreness and damage to the skin that can have a significant impact on quality of life.
VIOLET studies clinical investigator Jack Sobel said: “The current treatment approach for patients with RVVC is typically treatment of the acute infection each time one occurs.
“In some cases, this is followed by long-term suppressive therapy with oral fluconazole, a drug with a limited antifungal spectrum, and which has been associated with drug interactions and potential pregnancy effects.
“VT-1161 demonstrated a high degree of efficacy and safety during the Phase 2 REVIVE study. The low re-infection rates observed in the VT-1161 treated patients were very impressive compared to other therapies previously studied in RVVC.”
VT-1161 is an orally available inhibitor of fungal CYP51, and claims to feature greater selectivity, fewer side effects and improved potency.