In short
FB301 is an investigational live biotherapeutic product being studied for bacterial vaginosis (BV). It is a hard vaginal capsule containing 10 million CFU of bacteria, given vaginally. One Phase 2 trial, authorised in the EU, is testing FB301 after pre-treatment with chlorhexidine and/or metronidazole in 120 women with BV.
Key points
- FB301 is an investigational live biotherapeutic product, not yet authorised as a medicine.
- It is being studied in bacterial vaginosis, a common vaginal infection.
- The only trial is a Phase 2 study with 120 participants.
- FB301 is given as a hard vaginal capsule containing 10 million CFU.
- The trial measures the change in Lactobacillus crispatus and jensenii abundance in the vaginal microbiome.
- The trial is currently authorised in the EU.
What is FB301?
FB301 is an investigational live biotherapeutic product developed by Freya Biosciences APS. It is not yet authorised as a medicine anywhere in the EU product records. The substance is registered under the names FRE01, FRE02, FRE03 and FRE04, and the product name is FB301. It belongs to the therapeutic area of bacterial infections and mycoses. FB301 is a live biotherapeutic product, meaning it contains live bacteria intended to restore a healthy vaginal microbiome.
How does FB301 work?
FB301 is designed to restore the vaginal microbiome by increasing the relative abundance of Lactobacillus crispatus and Lactobacillus jensenii. These Lactobacillus species are considered beneficial bacteria that help maintain a healthy acidic vaginal environment and protect against pathogens. In bacterial vaginosis, the normal Lactobacillus-dominated microbiome is disrupted. FB301 is administered after pre-treatment with chlorhexidine vaginal antisepsis and/or oral metronidazole, which are intended to reduce the unwanted bacteria first.
Which conditions is FB301 being studied for?
- Bacterial vaginosis (BV) — a common vaginal infection caused by an imbalance in the vaginal microbiome, where harmful bacteria overgrow and beneficial Lactobacillus species decline.
How is FB301 given?
FB301 is given as a hard vaginal capsule for vaginal use. The dose used in the trial is 10 million colony forming units (CFU) per capsule. The product is part of a fixed combination in one product record, and in the trial it is given after pre-treatment with Arilin 500 mg film tablets (metronidazole, 1000 mg oral use) and/or Clorxil 5 mg/ml cutaneous solution (chlorhexidine, 30 ml vaginal use).
What do the clinical trials show?
There is one authorised Phase 2 interventional trial of FB301 in bacterial vaginosis, with 120 participants. The trial is titled "Chlorhexidine and/or metronidazole plus FB301 pre-treatment trial". The primary outcome is the change in the vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species, measured by metagenomic sequencing of vaginal samples from baseline to week 3. The trial aims to assess the impact of chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with BV.
Who can take part in the trial?
The trial enrols women with bacterial vaginosis. The register does not list further eligibility criteria for this trial.
What side effects are known?
No side effect information is provided in the available sources for FB301.