In our upcoming study EpHect, the objective is to increase our knowledge about the effect of pHyph treatment against fungal infection (Vulvo Vaginal Candiditis, VVC). The patients will be treated with one tablet a day for 6 consecutive days. This study will be held in collaboration with clinics in Sweden and recruitment of patient will be initiated soon.
VVC is very common and as many as 75% of women globally will have an infection at least once in their lives. Many of those will experience recurrent infections. The cause of VVC is usually Candida albicans, a fungal species that is naturally present on skin and mucous membranes, but can transform into a pathogenic form as a response to an imbalance in its environment.
The NEFERTITI study is now fully recruited with 150 patients in Great Britain and Sweden. The primary objective is to investigate clinical performance of pHyph for bacterial vaginosis. pHyph is a vaginal tablet and treatment schedule was 1 tablet a day for 6 consecutive days. Patients who were cured after the first treatment period were monitored for 4 months and given a preventive treatment with 1 tablet per week (placebo or pHyph).
Clinical study 2: Bacterial vaginosis
Clinical study 1: Vaginal Candidasis
Stability tests show that the tablet is stable in its blister pack for at least 18 months. The product has a current shelf life of 24 months.
In vitro data: Bacterial vaginosis
pHyph removes the biofilm, under which the harmful, pathogenic bacteria can hide and escape local treatments. Preclinical studies have verified that the API inhibits formation of biofilm and removes already established biofilm. Biofilm is commonly seen in bacterial vaginosis and is regarded as one of the main causes of recurrence of the infections. In addition, pHyph provides an environment for the restoration of the natural vaginal flora by restoring the normal vaginal pH. The pH-lowering effect, favours the good, protective bacteria which outcompete the harmful, pathogenic bacteria. In preclinical studies, the API of pHyph has been shown to preferentially affect bacteria species associated with recurrent bacterial vaginosis (e.g. Gardnerella vaginalis), over beneficial Lactobacillus species. By these means pHyph treats the bacterial vaginosis and reduces the risk of recurrence.
In vitro data: Candida fungus
Biological tests: Safety
1. Bacterial vaginosis is diagnosed by Amsel-criteria.
2. Vaginal candidosis is diagnosed by wet smear with potassium hydroxide.