Hyloris Pharmaceuticals SA announced positive results for the phase 2 trial of Miconazole Domiphen-Bromide (MCZ-DB) in patients with acute vulvovaginal candidiasis. The phase 2 trial of MCZ-DB was a 12-week, randomized, double-blind, active-controlled, dose finding trial evaluating the safety and efficacy of two doses of MCZ-DB (MCZ 2% combined with 0.14% or 0.29% of DB) administered once per day for 7 days in patients with acute vulvovaginal candidiasis. The study has been conducted in Belgium with a total of 102 patients enrolled.

Efficacy was evaluated by assessing the clinical outcome and mycological outcome to the treatment. A positive clinical outcome is a resolution of VVC signs and symptoms whereas the mycological outcome is determined by a vaginal swab indicating the absence of Candida species yeast. Top line results are summarized: At day 29, day 57 and day 85, the low dose (MCZ and 0.14% of DB) demonstrated superior efficacy compared to the active control (MCZ).

At day 15, both doses administered demonstrated positive safety and tolerability without significant superiority over the active control. MCZ-DB was well tolerated in both dose cohorts, with no reported serious adverse events. Following the treatments, there was no indication of systemic exposure to Domiphen Bromide.