A new, safe and resistance-free treatment of vaginal fungal and bacterial infections
|Coordinator||GEDEA BIOTECH AB - Medicon Village|
|Funding from Vinnova||SEK 3 000 000|
|Project duration||May 2019 - December 2020|
|Venture||Swelife and Medtech4Health - Collaborative Projects for Improved Health|
|Call||Swelife and Medtech4Health - Collaborative Projects for Improved Health (Spring 2019)|
Purpose and goal
Gedea Biotech develops an antibiotic-free, local treatment for vaginal fungal and bacterial infections. The vaginal tablet has undergone two initial clinical studies for the treatment of bacterial and fungal infections, with positive preliminary results. In the Project, the effect of the vaginal tablet aims to be verified in follow-up clinical studies on vaginal fungal and bacterial infection, as well as reach a CE-mark of the product. In addition, a market study of the patient journey is to be conducted.
Expected results and effects
The project is expected to provide a verification of the clinical effect for the treatment of vaginal fungal and bacterial infections and the patients´ user experience during treatment with Gedea´s vaginal tablet. The market investigation is expected to provide information on how patients treat today, when they seek care and the time aspects for treatment, care seekers etc.
Planned approach and implementation
A controlled clinical study of the effect of the vaginal tablet on the treatment of vaginal fungal and bacterial infections. The study will be conducted at four to five private gynecology clinics and in collaboration with the Clinical Trial Unit, Region Skåne. In addition to treatment results and user experience, the effect of the treatment on the vaginal microbiome will also be analyzed. The market survey will be conducted as questionnaires through social media.