Gedea Biotech announce start of the clinical study BV2025 following CE marking of pHyph —first patients enrolled

Lund, Sweden, January 22, 2026

Gedea Biotech today announced that the clinical trial BV2025 has started, following approval from the Swedish Medical Products Agency (Läkemedelsverket) for the treatment of bacterial vaginosis. In addition to fulfilling post-approval requirements, the results from BV2025 will also generate valuable data for the European market launch and executing collaborations for the U.S. market.

The BV2025 study is designed to include 32 patients treated with pHyph. The purpose of the study is to confirm the safety profile of pHyph, which has previously demonstrated excellent tolerability, and to evaluate clinical outcomes in the treatment of bacterial vaginosis according to Amsel criteria and Nugent score at day 7. The BV2025 study is conducted at two sites, in Stockholm and Uppsala respectively, and recruitment is ongoing via social media advertising as well as from regular patient inflow.

The first two patients have already been enrolled. Dr. Aino Fianu Jonasson and Dr. Hashem Amini serve as Principal Investigator for this trial.

“The approval and initiation of the BV2025 study are part of our post-approval follow-up plan as we continue to strengthen the clinical evidence for pHyph,” said Annette Säfholm, CEO at Gedea Biotech. “We are pleased to see that the first patients have already been enrolled, and we look forward to generating further data that will support both regulatory post-approval requirements and future partnerships,” Annette Säfholm concludes.