NEFERTITI clinical study
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.Patients who want to participate in the clinical trial should visit recruitment web page
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 results have been published in the European Journal of Obstetrics & Gynecology and Reproducxtive Biology
Clinical study 1: Candida albicans
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 theere were no o SAE (serious adverse events) and no unexpected AE (adverse events).
Stability Tests
Stability tests show that the tablet is stable in its blister for at least 12 months. The product will have a shelf life of 12 months.
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.
Upcoming
References:
1. Bacterial vaginosis is diagnosed by Amsel-criteria. 2. Vaginal candidosis is diagnosed by wet smear with potassium hydroxide.
1. Bacterial vaginosis is diagnosed by Amsel-criteria. 2. Vaginal candidosis is diagnosed by wet smear with potassium hydroxide.
