In short
FRE03 is an investigational substance being studied for bacterial vaginosis. It is a component of FB301, a vaginal capsule developed by Freya Biosciences APS, and currently has no marketing authorisation. One Phase 2 trial, authorised in the EU, is examining whether pre-treatment with chlorhexidine or metronidazole followed by FB301 can change the vaginal microbiome in 120 participants.
Key points
- FRE03 is an investigational substance with no marketing authorisation, developed by Freya Biosciences APS.
- It is given as a hard vaginal capsule and is part of the product FB301.
- One Phase 2 trial is authorised, studying bacterial vaginosis.
- The trial plans to enrol 120 participants.
- The main measure is the change in Lactobacillus crispatus and jensenii abundance in the vaginal microbiome.
- The trial compares pre-treatment with chlorhexidine and/or metronidazole before FB301.
What is FRE03?
FRE03 is an investigational substance that does not yet have a marketing authorisation, meaning it is not an approved medicine. It is listed in the EU Clinical Trials Information System (CTIS) under the therapeutic area of bacterial infections and mycoses, specifically being studied in bacterial vaginosis. The substance is developed by Freya Biosciences APS, a company based in Denmark.
FRE03 is one of several related substances recorded in the registry under the names FRE01, FRE02, FRE04 and FRE03, and it appears as part of the product FB301. The product records indicate that FB301 contains a fixed combination of substances.
How does FRE03 work?
The registry data do not describe the molecular mechanism of FRE03 in detail. However, the authorised trial aims to change the vaginal microbiome by increasing the relative abundance of Lactobacillus crispatus and Lactobacillus jensenii species. These bacteria are considered part of a healthy vaginal environment, and bacterial vaginosis is associated with a loss of such lactobacilli and an overgrowth of other bacteria. The trial therefore measures whether FRE03, given as FB301 after pre-treatment, can help restore a lactobacillus-dominant vaginal microbiome.
Which conditions is FRE03 being studied for?
The only condition in the registered trial is:
- Bacterial vaginosis — a common vaginal condition caused by an imbalance in the normal bacteria present in the vagina, often leading to discharge and odour.
How is FRE03 given?
According to the product records, FRE03 is formulated as a hard vaginal capsule for vaginal use. In the authorised trial, FB301 is administered vaginally at a dose of 10 million colony forming units (CFU). The trial also uses two other products as pre-treatment: Arilin 500 mg film-coated tablets (metronidazole) taken orally at a dose of 1000 mg, and Clorxil 5 mg/ml cutaneous solution (chlorhexidine) applied vaginally at a volume of 30 ml.
What do the clinical trials show?
One trial is registered for FRE03. It is a Phase 2, interventional study that has been authorised in the EU, meaning it has received regulatory approval to begin but may not yet be recruiting. The trial plans to enrol 120 participants with bacterial vaginosis.
The study is designed to assess the impact of chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 on the vaginal microbiome. The primary outcome is the change in relative abundance of combined Lactobacillus crispatus and jensenii species, measured by metagenomic sequencing of vaginal samples taken from baseline (Visit 2) to Week 3 (Visit 3). Metagenomic sequencing is a laboratory method that identifies all the genetic material in a sample, allowing researchers to see which bacteria are present and in what proportions.