In short
Escherichia coli, strain V121, inactivated is a bacterial immunotherapy studied as part of the investigational product MV140 for recurrent non-complicated urinary tract infections (rUTIs). It is not authorised as a medicine in these product records and is currently being tested in a Phase 3 trial involving 252 women with recurrent cystitis without risk factors. The trial compares MV140 with placebo over 15 months to see whether it reduces new UTI episodes.
Key points
- Phase 3 trial in recurrent non-complicated urinary tract infections in women without risk factors.
- 252 participants are planned to be enrolled in the trial.
- The trial is authorised and compares MV140 with placebo.
- The main outcome is the number of new UTI episodes over 15 months.
- MV140 is given as a sublingual spray containing four inactivated bacterial strains.
- The substance is investigational with no marketing authorisation in the product records.
What is Escherichia coli, strain V121, inactivated?
Escherichia coli, strain V121, inactivated is an inactivated bacterial strain. It is one of four inactivated bacterial strains contained in the investigational product MV140, which is being developed as a mucosal bacterial therapeutic vaccine. The other strains in this fixed combination are Klebsiella pneumoniae, strain V113, inactivated, Enterococcus faecalis, strain V125, inactivated, and Proteus vulgaris, strain V127, inactivated. The substance is classified in the therapeutic area of bacterial infections and mycoses. It has no marketing authorisation in the product records and remains an investigational substance. The authorisation holder listed in the records is INMUNOTEK S.L.
How does Escherichia coli, strain V121, inactivated work?
The exact mechanism of action of Escherichia coli, strain V121, inactivated is not described in detail in the available registry data. As part of MV140, it is described as a mucosal bacterial therapeutic vaccine intended to reduce the number of new episodes of recurrent urinary tract infection. The trial record states that the product is being evaluated for its efficacy in reducing the number of episodes of rUTI compared with placebo during 15 months after the beginning of the trial intervention. The term mucosal immunotherapy refers to the route by which the product is given, under the tongue, and the aim of influencing the immune response at mucosal surfaces such as the urinary tract.
Which conditions is Escherichia coli, strain V121, inactivated used or studied for?
The substance is studied for one condition in the available trial data:
- Recurrent non-complicated urinary tract infections (rUTIs) — repeated urinary tract infections in women without risk factors, also described as localized recurrent cystitis.
Urinary tract infections are infections of the urinary system, most often the bladder. Recurrent means that the infections come back repeatedly. Non-complicated means that the infections occur in people without underlying anatomical or functional abnormalities of the urinary tract.
How is Escherichia coli, strain V121, inactivated given?
Escherichia coli, strain V121, inactivated is given as part of the product MV140 in the form of a sublingual spray, suspension for sublingual use. The trial lists a dose of 0.2 ml for the MV140 product, administered under the tongue. Sublingual use means the product is sprayed under the tongue, where it is absorbed through the mucous membrane. The trial also includes comparison arms with oral antibiotics: nitrofurantoin 100 mg, fosfomycin 3 g, and pivmecillinam 1200 mg.
What do the clinical trials show?
One clinical trial is listed in the data for Escherichia coli, strain V121, inactivated as part of MV140.
Which conditions are studied?
The single Phase 3 trial studies recurrent non-complicated urinary tract infections (rUTIs) in women with localized recurrent cystitis without risk factors.
What phase and status does the trial have?
The trial is a Phase 3 interventional study with the status Authorised. Phase 3 means the product is being tested in a larger group of participants to confirm its efficacy and safety.
What does the trial measure?
The primary outcome is the number of new episodes of UTIs confirmed both by the presence of symptoms and a positive urine culture during 15 months after the beginning of the trial intervention, and the percentage of patients who show new UTI episodes in this period. Symptoms listed in the trial include dysuria, overactive bladder, frequent and sudden urge to urinate, pelvic pain, pollakiuria, turbid white urine, haematuria, foul-smelling urine, polyuria, urinary itching, and urgency of urination.
Who can take part?
The trial enrols 252 women with localized recurrent cystitis without risk factors. The trial compares MV140 with placebo, and also includes oral antibiotic arms with nitrofurantoin, fosfomycin, and pivmecillinam.
What side effects are known?
The available registry data does not provide information on side effects for Escherichia coli, strain V121, inactivated or the MV140 product. The trial is designed to evaluate safety as part of its Phase 3 assessment, but no specific side effect data are reported in the records.