Gedea Biotech completes VVC-2025 study and advances product expansion to treat vaginal fungal infections
Gedea Biotech today announced continued progress in its strategy to expand the CE-marked indications for pHyph to include the treatment of vulvovaginal candidiasis (VVC), commonly known as vaginal fungal infection.
The company has completed the clinical study, VVC-2025 and continues to advance the review process for expanding the existing CE-mark to include the treatment of VVC. The first-in-class product, pHyph, is already approved for the treatment of vaginal bacterial infections (bacterial vaginosis, BV) and to maintain a healthy microbiome.
VVC-2025 is a randomised, controlled study aiming to confirm the safety and efficacy of pHyph in the treatment of VVC, previously demonstrated in a single-arm study. Results from an interim analysis (including 36 women with VVC) demonstrated encouraging efficacy outcomes consistent with previous studies. Women treated with pHyph showed greater improvement in signs and symptoms associated with VVC, and statistically significant clinical cure rates on Day 14. In the interim analysis, the primary endpoint for signs and symptoms improvement on Day 7 was however not met. Consistent with previous studies, no safety concerns were reported during the study.
Overall, the study further strengthens the body of clinical evidence supporting pHyph in treatment of VVC and enables Gedea Biotech to continue its CE mark expansion strategy, without further continuation of patient enrolment in the VVC-2025 study. The Notified Body review of the application to include VVC as an approved indication is progressing.
“We are pleased with the progress of our VVC program and believe the clinical evidence generated to date provides a strong foundation for expanding pHyph’s clinical use,” said Julie Waras Brogren, CEO of Gedea Biotech. “Our goal is to provide women an innovative, antibiotic-free option that broadly addresses common vaginal infections reducing the risk of incorrect treatment and long-term symptoms.”
VVC affects an estimated 175 million world-wide every year, and most women will experience at least one episode during their lifetime. Symptoms significantly impact quality-of-life and can be difficult to distinguish from those of BV, making accurate diagnosis challenging and inappropriate treatment common.
The VVC-2025 study was funded by the EIC grant awarded to Gedea Biotech in 2024.
For further information, please contact:
Julie Waras Brogren, CEO Gedea Biotech
Phone: + 46 73-352 67 63
Email: julie.brogren@gedeabiotech.com
About pHyph
pHyph is a CE-marked, antibiotic-free vaginal tablet approved under the EU Medical Device Regulation (MDR) for the treatment of bacterial vaginosis (BV) and for promoting a healthy vaginal microbiome. By restoring the vaginal environment and supporting beneficial lactobacilli, pHyph provides an innovative alternative to conventional treatments. The product is developed by Gedea Biotech to address a significant unmet need for safe and effective treatments that support long-term vaginal health.
About Gedea Biotech
Gedea Biotech AB is a Swedish women's health company on a mission to make a sustainable impact to global women’s health with a modern, antibiotic-free treatment for common vaginal infections that women can trust for long-term effect, available when they need it. Its lead product pHyph is CE-marked under the EU Medical Device Regulation (MDR) for the treatment of bacterial vaginosis and promotion of a healthy vaginal microbiome. Gedea is a spin out from Lund University and is based in Lund, Sweden. www.gedeabiotech.se
This project is supported by the European Innovation Council
The European Innovation Council is Europe’s flagship innovation programme to identify, develop and scale up breakthrough technologies and game changing innovations The EIC has been established under the EU programme. It has a budget of €10.1 billion to support game changing innovations throughout the lifecycle from early stage research, to proof of concept, technology transfer, and the financing and scale up of start-ups and SMEs.