Lund, Sweden – 22 July 2026
Gedea Biotech today announced the successful completion of the BV2025 post market clinical study. The study with the vaginal tablet pHyph met its primary endpoint confirming the favourable safety and tolerability in women with bacterial vaginosis (BV). Clinical cure rates were consistent with previous trials and further strengthening the clinical evidence supporting pHyph as a safe, effective and antibiotic-free treatment for bacterial vaginosis.
BV-2025 was conducted as part of the post-market clinical follow-up program for pHyph following approval under the EU Medical Device Regulation (MDR) in August 2025. The primary endpoint was to assess safety and local tolerability of pHyph in women treated with for bacterial vaginosis. The study successfully met its endpoint and no new safety concerns were identified. For clinical cure efficacy, results were positive and conclusions remain in line with previous studies. The data from BV2025 are valuable for the European market launch and executing collaborations for the US market.
“The completion of BV-2025 represents an important milestone for Gedea. Together with previous clinical studies, the findings contribute to an increasingly consistent body of evidence supporting pHyph as a safe, effective and antibiotic-free treatment approved in Europe for the treatment of bacterial vaginosis. In addition, it demonstrates our ability to efficiently execute clinical and regulatory commitments according to plan”, says Julie Waras Brogren, CEO of Gedea Biotech.
“These findings are consistent with growing body of evidence supporting pHyph as a safe and effective treatment option for bacterial vaginosis”, says Helena Litorp, MD, PhD, Associate Professor and specialist physician in obstetrics and gynecology as well as Principal Investigator of the BV-2025 study.