In short
Enterococcus faecalis, strain V125, inactivated is a bacterial component of an investigational sublingual spray being studied for recurrent non-complicated urinary tract infections (rUTIs). It is part of a fixed combination with three other inactivated bacteria, known as MV140, developed by Inmunotek S.L. A Phase 3 trial (2025-524377-16-00) is currently authorised to compare this combination against placebo in 252 women with recurrent cystitis.
Key points
- Phase 3 trial authorised to confirm efficacy and safety in women with recurrent non-complicated urinary tract infections.
- 252 participants are planned for enrolment in the trial.
- The substance is given as a sublingual spray containing inactivated whole bacteria.
- The trial compares the bacterial combination MV140 against placebo over 15 months.
- The main measure is the number of new UTI episodes confirmed by symptoms and positive urine culture.
- This is an investigational substance with no marketing authorisation in the product records.
What is Enterococcus faecalis V125?
Enterococcus faecalis, strain V125, inactivated is a bacterial preparation made from whole, killed bacteria. It is one of four inactivated bacterial strains that together form a fixed combination product. The other three strains are Klebsiella pneumoniae V113, Escherichia coli V121, and Proteus vulgaris V127, all inactivated. This combination is known under the development name MV140.
The substance is classified in the therapeutic area of bacterial infections and mycoses. According to the product records, it is an investigational substance with no marketing authorisation. The authorisation holder and supplier of the product is Inmunotek S.L.
How does Enterococcus faecalis V125 work?
The product is described as a mucosal bacterial therapeutic vaccine. It is given under the tongue, where it comes into contact with the mucosal immune system. The aim of this approach is to train the immune system to recognise common bacteria that cause urinary tract infections, so that the body can respond more effectively when it encounters these bacteria again. The trial summary states that the goal is to reduce the number of new episodes of recurrent urinary tract infection.
Which conditions is it used or studied for?
- Recurrent non-complicated urinary tract infections (rUTIs) — repeated bladder infections in women who have no known anatomical or functional abnormalities of the urinary tract that would make the infections complicated. The authorised trial focuses on women with localised recurrent cystitis without risk factors.
How is Enterococcus faecalis V125 given?
The product is formulated as a sublingual spray, suspension. It is administered by the sublingual route, which means it is sprayed under the tongue. In the trial, the dose recorded for the combination product is 0.2 ml given sublingually.
What do the clinical trials show?
One trial is registered for this substance. It is a Phase 3 trial with the EU CT number 2025-524377-16-00, currently with the status Authorised. The trial is designed to confirm efficacy, safety, and clinical impact of the bacterial mucosal immunotherapy compared with placebo in women with localised recurrent cystitis without risk factors. A total of 252 participants are planned.
The trial compares the MV140 bacterial combination against placebo. In addition, the trial protocol includes three antibiotic drugs as separate interventions: nitrofurantoin 100 mg oral, fosfomycin 3 g oral, and pivmecillinam 1200 mg oral. These antibiotics are part of the trial design and are not part of the MV140 combination.
The main outcome measure is the number of new episodes of urinary tract infection during 15 months after the beginning of the trial intervention. An episode is defined by the presence of symptoms such as pain or burning when passing urine, frequent and sudden urge to urinate, pelvic pain, cloudy or foul-smelling urine, or blood in the urine, together with a positive urine culture. The trial will also measure the percentage of patients who show new UTI episodes in this period.
What side effects are known?
No side effect data for Enterococcus faecalis V125 or the MV140 combination is provided in the available sources.