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.

The Nefertiti-2 study

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

The clinical study NEFERTITI, a placebo-controlled, double blinded study, enrolled 152 patients on sites in Great Britain and Sweden. Patients diagnosed with bacterial vaginosis were included according to the acknowledged Amsel criteria (at least 3 out of 4 Amsel criteria for diagnosis). Patients were treated with pHyph or placebo daily from day 0 to day 6 and examined at day 7. Patients cured, were followed for 4 months, and were administrated 1 tablet/ week (pHyph or placebo) for prevention of recurrence during this time period. Patients not cured were given antibiotics as rescue treatment and were also followed for recurrence. Symptom reduction was seen in 90% of patients treated with pHyph and absence of symptoms was noted in 70%. The cure rate was 50.4% after 7 days. Recurrence rate at day 35 was 13.9% for the pHyph treated patients, considerably lower than for the placebo treated patients, 27% and the lower recurrence rate was seen in the patients treated with pHyph throughout the 4 months follow-up period. There were no SAE (serious adverse events) and no unexpected AE (adverse events). The results are planned to be published in a scientific paper.

Clinical study 2: Bacterial vaginosis

The clinical study in bacterial vaginosis was conducted at two gynecology clinics in Southern Sweden in 2019. A total of 24 patients with bacterial vaginosis were included according to the acknowledged Amsel criteria (at least 3 out of 4 Amsel criteria for diagnosis). Patients were treated with pHyph days 0, 2, 4 and 6 and if they were not clinically cured (defined as absence of all Amsel criteria) at the follow-up visit on day 7, treatment continued on days 7, 9, 11 and 13. Patients were aged 18-49 and the median age was 33 years. Eighty two percent of patients were clinically cured (none of the three Amsel Criteria remaining) at day 7. Recurrence rate at day 35 was 5.6%.There were no SAE (serious adverse events) and no unexpected AE (adverse events). The results have been published in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

Clinical study 1: Vaginal Candidiasis

In the study, patients with vaginal fungal infection were treated with pHyph for one week. The aim of the study was to ensure that pHyph is effective in treating the infection and that patients experience the treatment as safe and effective. The result showed promising signs of efficacy and there were no SAE (serious adverse events) and no unexpected AE (adverse events).

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

pHyph has been studied in laboratory tests and shown to be effective on the 5 most common Candida fungus species. The test results show that pHyph breaks down the Candida biofilm build-up and restores the healthy, protective vaginal microbiome which counteracts the Candida infection and its recurrence. The microbiome data from the initial clinical study indicates that these mechanisms are important for the clinical effect in treating vaginal candida infections.

Biological tests: Safety

Biological tests have been completed showing that the vaginal tablets do not cause irritation, sensibilisation or cell damage.

References:
1. Bacterial vaginosis is diagnosed by Amsel-criteria.
2. Vaginal candidosis is diagnosed by wet smear with potassium hydroxide.