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Studies

During the Autumn of 2018 the first clinical study on pHyph will take place. The expected outcome of planned studies is that pHyph will prove to have an effect on both fungal infection and bacterial vaginosis. Gynaecologists in Skåne will be participating and offering pHyph as a treatment for vaginal thrush or bacterial vaginosis. If the patient declines to participate, the patient will receive standard treatment for the condition respectively.

UPCOMING

  • 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.

  • 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.

ONGOING

  • Biological tests

    Biological tests are ongoing in order to evaluate the safety and tolerability of the vaginal tablets and to ensure they do not cause irritation or cell damage.

  • Stability Tests

    Stability tests are ongoing in order to ensure that the vaginal tablets are stable in their final packaging prior to clinical studies.

FINISHED

  • 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.

  • 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.

 

 

Reference: Vaginal candidosis is diagnosed by wet smear with potassium hydroxide. 2. Bacterial vaginosis is diagnosed by Amsel-criteria.
kartaGedea Biotech AB
Medicon Village
Scheelevägen 2
223 81 Lund
Sweden
Annette Säfholm, CEO
annette.safholm@gedeabiotech.com
+46 (0) 708 - 91 86 81
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