Clinical program
EpHect Study: Vaginal Yeast Infection
The EpHect study has been completed, and analysis of the results is currently underway.
The patients in the study had vaginal fungal infections (vulvovaginal candidiasis) and were treated with one vaginal tablet of pHyph per day for 6 consecutive days. The study was conducted in collaboration with four gynecological clinics in Sweden.
Vulvovaginal candidiasis is very common, with as many as three-quarters of women worldwide experiencing a yeast infection at least once during their lifetime. Additionally, many experience recurring infections. Vaginal yeast infections are typically caused by Candida albicans, a type of fungus that is part of the normal flora on the skin and mucous membranes but can transition to a infectious state when there is an imbalance in its environment.
Bacterial vaginosis is a common condition, with a worldwide prevalence of 23-27%. The primary symptom of bacterial vaginosis is malodorous discharge, caused by an imbalance of bacteria normally present in the vagina.
In the NEFERTITI-2 study the effectiveness of pHyph in treating bacterial vaginosis is evaluated. Women experiencing bacterial vaginosis are invited to participate in the study and undergo treatment with pHyph vaginal tablets for six consecutive days. Patients who complete the treatment and achieve recovery will receive follow-up maintenance therapy for two months to prevent recurrence.
The study fully recruited and results are expected in the end of this year.
Completed studies
Clinical study 3: NEFERTITI, Bacterial vaginosis
Clinical study 2: Bacterial vaginosis
Clinical study 1: Vaginal Candidiasis
Stability Tests
Stability tests show that the tablet is stable in its blister pack for at least 24 months. The product has a current shelf life of 36 months.
In vitro data: Bacterial vaginosis
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 addition, pHyph removes the biofilm, under which the harmful, pathogenic bacteria can hide and escape local treatments. Preclinical studies have verified that the active substances 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 preclinical studies, the active substances of pHyph has been shown to preferentially affect bacteria species associated with recurrent bacterial vaginosis (e.g. Gardnerella vaginalis), over beneficial Lactobacillus species, especially L.crispatus. 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.