Studies
The first clinical studies on pHyph are ongoing. The expected outcome of planned studies is that pHyph will prove to have an effect on bacterial vaginosis. Gynaecologists in Skåne are participating and offering pHyph as a treatment for bacterial vaginosis. If the patient declines to participate, the patient will receive standard treatment for the condition respectively.-
Clinical trial
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.
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Clinical study 1: Candida albicans
In the study, patients with vaginal fungal infection are treated with a vaginal tablet containing pHyph. The aim of the study is to ensure that pHyph is effective in treating the infection and that patients experience the treatment as safe and effective. The study is estimated to last three months.
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Clinical study 2: Bacterial vaginosis
In the study, patients with bacterial vaginosis receive treatment with pHyph. The aim of the study is to show that a vaginal tablet containing pHyph can cure the bacterial infection in a safe and and effective way. This study is also expected to last for three months.
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Biological tests
Biological tests have been completed showing that the vaginal tablets do not cause irritation or cell damage.
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In vitro data: Fungi
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.
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Stability Tests
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.
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In vitro data: Bacterial vaginosis
pHyph has a verified pH-lowering effect. The relation between decreasing pH and effectively treating bacterial vaginosis is established and well-known.
