Studies

Gedea has an ambitious clinical programme to ensure that pHyph is effective in treating and preventing recurrense of vaginal infections and that patients experience the treatment as safe and effective.

Finished

Clinical study 2: Bacterial vaginosis

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).1 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.

Clinical study 1: Candida albicans

In the study, patients with vaginal fungal infection2 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.

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.

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.

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.

Biological tests

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

Ongoing

Clinical trial 3: NEFERTITI Bacterial Vaginosis 

NEFERTITI aims to recruit 150 adult women aged 18 or over with bacterial vaginosis diagnosed by Amsel’s* criteria and is due to start in late 2020. The primary objective is to investigate clinical performance of pHyph – in a smaller study reported earlier this year 82% of the women were clinically cured, defined as absence of all Amsel criteria, after 7 days. This corresponds to existing antibiotic-based treatment. After the first treatment period (day 0-7), patients that are cured will be randomized to preventive treatment, and given one tablet a week of pHyph or placebo, for four months. The follow up period will provide important data on pHyph´s impact on prevention of recurrent infections and the effect on the microbiome.

Upcoming

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