In short
FRE02 is an investigational live biotherapeutic product being studied for bacterial vaginosis. It is part of a fixed combination product called FB301, developed by Freya Biosciences APS. One authorised Phase 2 trial is currently evaluating whether pre-treatment with chlorhexidine and/or metronidazole followed by FB301 can improve the vaginal microbiome in 120 women with bacterial vaginosis.
Key points
- FRE02 is an investigational live biotherapeutic product with no marketing authorisation.
- It is being studied in bacterial vaginosis in one authorised Phase 2 trial.
- The trial plans to enrol 120 women with bacterial vaginosis.
- FRE02 is given as a vaginal capsule under the product name FB301, at a dose of 10 million CFU.
- The main measure is the change in vaginal microbiome, specifically the combined relative abundance of Lactobacillus crispatus and jensenii.
- The trial is currently authorised but not yet recruiting.
What is FRE02?
FRE02 is an investigational substance with no marketing authorisation in the product records, meaning it is not yet approved as a medicine. It is part of a fixed combination product called FB301, developed by Freya Biosciences APS. The substance belongs to the therapeutic area of bacterial infections and mycoses. FRE02 is classified as a live biotherapeutic product, meaning it contains live microorganisms intended for therapeutic use.
How does FRE02 work?
The trial record describes FB301 as a product containing Lactobacillus crispatus and jensenii species, which are bacteria naturally found in a healthy vaginal microbiome. The treatment approach aims to restore a healthy balance of these Lactobacillus species in the vagina after pre-treatment with antimicrobial agents. The primary outcome measures the change in the relative abundance of these combined Lactobacillus species from baseline to week 3.
Which conditions is FRE02 being studied for?
- Bacterial vaginosis — a common vaginal condition caused by an imbalance in the natural bacteria of the vagina, which the trial aims to address by restoring Lactobacillus species.
How is FRE02 given?
FRE02 is given as a hard vaginal capsule for vaginal use. In the trial, FB301 is administered at a dose of 10 million colony forming units (CFU). The trial also includes pre-treatment with chlorhexidine vaginal solution and/or oral metronidazole tablets, which are used as comparison interventions to prepare the vaginal environment before FB301 administration.
What do the clinical trials show?
One Phase 2 interventional trial is authorised to study FRE02 as part of the FB301 combination product. The trial plans to enrol 120 women with bacterial vaginosis. The study is currently authorised, which means it has received regulatory approval to proceed but has not yet started recruiting participants.
The main outcome being measured is the change in the vaginal microbiome, specifically the combined relative abundance of Lactobacillus crispatus and jensenii species, measured by metagenomic sequencing of vaginal samples from baseline (Visit 2) to Week 3 (Visit 3). The trial compares FB301 treatment after pre-treatment with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole.