In short
Proteus vulgaris, strain V127, inactivated is one of four inactivated bacterial strains in MV140, an investigational sublingual spray being studied for the prevention of recurrent non-complicated urinary tract infections (rUTIs) in women. The product is currently in a Phase 3 trial with 252 participants, comparing MV140 against placebo over 15 months to see whether it reduces new UTI episodes.
Key points
- MV140 is a sublingual spray containing four inactivated bacterial strains, including Proteus vulgaris, strain V127.
- The ongoing Phase 3 trial is testing MV140 against placebo in 252 women with recurrent non-complicated urinary tract infections.
- The trial is currently authorised and will follow participants for 15 months after starting treatment.
- The primary outcome is the number of new UTI episodes confirmed by symptoms and a positive urine culture.
- MV140 is given as a 0.2 ml sublingual spray and is not yet authorised as a medicine.
What is Proteus vulgaris, strain V127, inactivated?
Proteus vulgaris, strain V127, inactivated is an inactivated bacterial strain. It is one of four bacterial strains that together form the investigational product MV140, a mucosal bacterial immunotherapy. The other three strains in the fixed combination are Klebsiella pneumoniae, strain V113, inactivated; Escherichia coli, strain V121, inactivated; and Enterococcus faecalis, strain V125, inactivated.
The product has no marketing authorisation in the product records and is therefore an investigational substance. The authorisation holder and supplier named in the records is INMUNOTEK S.L. The therapeutic area is bacterial infections and mycoses.
How does Proteus vulgaris, strain V127, inactivated work?
The product is described in the trial record as a mucosal bacterial therapeutic vaccine. It is given under the tongue (sublingually), where it is intended to stimulate a mucosal immune response against the bacteria that commonly cause urinary tract infections. The exact mechanism is not described in detail in the registry data.
Which conditions is Proteus vulgaris, strain V127, inactivated used or studied for?
- Recurrent non-complicated urinary tract infections (rUTIs) — repeated urinary tract infections in women without risk factors, the condition being studied in the current Phase 3 trial.
How is Proteus vulgaris, strain V127, inactivated given?
The product is formulated as a sublingual spray, suspension. In the trial, MV140 is given as a 0.2 ml dose by sublingual use. The trial also includes oral antibiotics as comparison or rescue treatments: nitrofurantoin 100 mg, fosfomycin 3 g, and pivmecillinam 1200 mg, all by oral use.
What do the clinical trials show?
One trial is registered for this substance combination: a Phase 3, interventional trial comparing MV140 with placebo in 252 women with recurrent non-complicated urinary tract infections. The trial is authorised but results are not yet reported in the registry.
The primary outcome is the number of new episodes of UTI during 15 months after the beginning of the trial intervention, confirmed both by the presence of symptoms — such as dysuria (painful urination), overactive bladder, frequent and sudden urge to urinate, pelvic pain, pollakiuria (abnormally frequent urination), turbid white urine, haematuria (blood in the urine), foul-smelling urine, polyuria (excessive urine production), urinary itching, and urgency of urination — and a positive urine culture. The trial also measures the percentage of patients who show new UTI episodes in this period.
Participants are women with localised recurrent cystitis without risk factors. The trial compares MV140 against placebo, with oral antibiotics (nitrofurantoin, fosfomycin, pivmecillinam) included as additional interventions.
What side effects are known?
No side effect data are provided in the registry record for this trial. Side effects for MV140 are not described in the available sources.