Prof-001 (Candiplus®) - Phase 3
Last patient - An enormously important milestone successfully completed!
ProFem announces start of phase IIb/III study
The phase IIb/III study, which will start in November, aims to demonstrate the improved efficacy of Candiplus compared to the current gold standard therapy. The study will investigate the primary response rate in the acute phase as well as the relapse frequency during the maintenance therapy and the follow-up phase. The study is being conducted in a total of 430 patients in study centers in Austria, Poland, Slovakia and Russia. Candiplus® is based on a new therapeutic strategy for the treatment of frequently recurring vaginal fungal infections, and aims to achieve a sustainable cure of the disease.
The study is conducted in Austria in Vienna, Carinthia, Tyrol and Vorarlberg.
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First results of the Candiplus ®- Phase IIa study
The results of a phase II a - dose escalation/proof of concept - study with Candiplus® show a significantly improved cure rate in patients with vulvovaginal fungal infections.
The clinical study, which was conducted between May 2017 and July 2018, showed a significantly improved primary cure rate with Candiplus® compared to standard treatment, particularly in patients with frequently recurring vaginal mycosis. Pain relief of > 50% in pain intensity started within 12 to 24 hours. Further results suggested a trend toward a reduction in relapse rate of 50% compared with the comparator drug within the 2-month follow-up period. In summary, the study provided evidence for a novel mode of action to overcome biofilm resistance mechanisms.
Start of Phase II
ProFem announces start of Phase II dose escalation study with Candiplus® in patients with vulvovaginal candidiasis (VVC).
Starting in May 2017, patients with vulvovaginal candidiasis will be enrolled in an Austria-wide multicenter study to investigate the efficacy of a new drug for the treatment of vaginal mycosis (Candiplus®). A total of 84 patients will participate in study centers throughout Austria. The objective is to determine whether Candiplus® outperforms the current standard of care in achieving the combined primary study endpoint of symptom relief within the first hour and clinical cure after an active treatment period.
Candiplus® is based on a new therapeutic strategy combining two agents already available on the market for the treatment of acute and recurrent VVC, targeting a pathogenic mechanism previously ignored in therapy.