Ongoing studies:

EpHect study

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.

Nefertiti study
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).

Completed studies

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).¹ 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 Reproducxtive Biology.

Clinical study 1: Vaginal Candidasis

In the study, patients with vaginal fungal infection² were treated with pHyph for one week, 6 doses. 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 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

pHyph has been studied in laboratory tests for evaluation on its´ effect on the 5 most common varieties of Candida fungus. The test results shows that pHyph breaks down the Candida biofilm build-up and transforms the pathogenic form of the fungus to a non-pathogenic form. These results indicate that this processes will occur in our clinical trials as well.

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.