A new, safe and resistance-free treatment of vaginal fungal and bacterial infections

Important results from the project

The project´s objective was met when we conducted a controlled clinical study in which 152 patients were recruited to ensure the efficacy and safety of Gedea´s vaginal tablet pHyph in the treatment of ongoing vaginal infection. In the follow-up part of the study, the risk of recurrence was investigated for cured patients with a placebo-controlled maintenance treatment for 4 months. During the project, we also conducted a market study and verified the clinical/regulatory strategy for the US with an FDA meeting. The study is expected to lead to CE marking approval of the product.

Expected long term effects

The initial part of the clinical study has shown an effect on the treatment of ongoing bacterial vaginosis and symptom reduction in patients and that the product is user-friendly and safe. The effect of the treatment on the vaginal microbiome will be analysed after project completion. The market research gave us valuable information about the patient journey, which treatments are mainly used, risk of relapse and perceived side effects and the patients´ own assessment of what is significant about a new product. The expected result of the project has thus been met.

Approach and implementation

We have conducted a clinical study where a total of 152 patients have been recruited at four gynecological clinics in Sweden and six gynecological clinics in the UK. The corona pandemic caused delays in both the approval process and patient recruitment, and the FDA meeting had to be conducted digitally. A web-based market study in which over a thousand patients with vaginal infections participated was conducted in collaboration with the Clinical Trial Unit, Region Skåne, to examine the patient journey in detail. A white paper report summarizes the most important insights of the study.

External links

Gedea Biotech´s webpage.