Gedea Biotech has announced that all patients have been recruited for the multi-center study evaluating the clinical performance of an antibiotic-free treatment for vaginal infections.
This pilot study marks the start of a clinical development program of a treatment with dual effect, targeting both vaginal bacterial and fungal infections. The study will be followed by a proof of concept study to be initiated next year. The program is supported by Horizon 2020 and SweLife. Gedea was recently awarded € 3M in support of the Horizon 2020 program and this will accelerate the progress of the clinical program, states the company.
“We are pleased to have completed recruitment for this multicenter trial which will add to the growing body of clinical evidence for our approach. Our trial program is progressing well and will be boosted by our recent EU Horizon 2020 grant,” says Annette Säfholm, Gedea Biotech’s CEO.
About the study
The open-label single-armed, multi-center study has been designed to evaluate clinical performance, tolerability, and safety of the local treatment in 24 adult women with vulvovaginal candidiasis (VVC). On the first visit patients have a gynecological examination, vaginal samples taken, and receive the investigational product for self-administration. Patients are re-examined after 7 days with respect to VVC signs and symptoms and if not cured, receive prolonged treatment for one additional week. The recurrence of the infection is followed for five weeks post treatment. In the study, the vaginal microbiome is also investigated prior to and after treatment, as well as after the five-week follow-up period to investigate how the treatment affects the protective vaginal lactobacilli.
Results are expected in Q2, 2020.
Photo of Annette Säfholm: Gedea Biotech