News

November 2019

Profem announces start of Phase 2b study

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.

September 2018

Top line data from a Phase IIa - Dose Escalation/PoC Study with Candiplus® show significantly improved cure rates in patients with recurrent vulvovaginal yeast infections

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.

April 2017

ProFem announces start of the Phase II Dose Escalation Study with Candiplus® in patients with vulvovaginal candidiasis (VVC)

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.