Studies

In 2020, a larger clinical trial for patients with bacterial vaginosis will start. The aim of the study is to ensure that pHyph can both cure bacterial vaginosis and prevent re-infection. The study will be placebo controlled.

The clinical study in bacterial vaginosis was conducted at two gynecology clinics in Skåne 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 healthy 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 33 years.   82 % of patients were clinically cured (none of the three Amsel Criteria) at day 7. There were no SAE (serious adverse events) and no unexpected AE (adverse events). The full results will be presented at a scientific conference in spring 2020.

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

pHyph has been tested in the laboratory environment to investigate its effect on the five most common types of candida fungi. The tests show that pHyph breaks down the biofilm that the fungus creates and causes the fungus to pass from an infectious to a non-infectious form. In vitro results indicate that the effect will be repeated in the clinical study.

Stability tests Stability tests for 3 and 6 months have been completed and show that the vaginal tablets are stable in their blister packs in both room temperature and at higher temperature and humidity (so-called accelerated conditions). Tests to evaluate stability for a long time are ongoing.

pHyph has a verified pH-lowering effect. The relation between decreasing pH and effectively treating bacterial vaginosis is established and well-known.