The ProF-001_IIb study is a randomized, active-controlled, double-blind, double-dummy study in patients with recurrent vulvovaginal candidiasis, to evaluate efficacy, safety and tolerability of topically administered Candiplus® vs. oral Fluconazole. 430 patients will be enrolled in study centers across Austria, Poland, Slovakia and Russia. The aim is to evaluate clinical cure and relapse rates after treatment with Candiplus®, compared to standard of care (Fluconazole). Candiplus® is based on a new therapeutic strategy for the treatment of acute episodes and prevention of recurrent VVC, addressing a hitherto unaddressed pathogenetic mechanism.
The clinical study, performed between May 2017 and July 2018, showed significantly improved cure rates in acute episodes of RVVC patients (short-term therapy) for Candiplus, compared to topical Clotrimazole. Rapid onset of pain relief with a reduction of pain intensity >50% was obtained within 12-24 h. Further results suggested a trend towards reduction of relapse rates by 50% vs. comparator within the 2-month follow-up period and provided proof of concept for a new mode of action to overcome biofilm resistance mechanisms.
The ProF-001_IIa study is a randomized, active-controlled, double-blind, dose-escalation study in patients with vulvovaginal candidiasis, to evaluate efficacy, safety and tolerability of topically administered Candiplus®. The study will enroll 84 patients in three study centers across Austria. The aim is to evaluate whether Candiplus® is superior to standard of care in the combined primary endpoint of symptom relief within the first hour, and clinical cure after the active treatment period. Candiplus® is based on a new therapeutic strategy, consisting of a combination of two already marketed active ingredients for the treatment of acute and recurrent VVC, addressing a hitherto unaddressed pathogenetic mechanism.