CONCENTRATION SOLUTION OF KAYVIRUS DSM 33473, KAYVIRUS DSM 33474, AND PBUNAVIRUS DSM 33593

It is applied topically to infected wounds and is being studied for the treatment of wounds colonised or infected with Staphylococcus aureus and/or Pseudomonas aeruginosa. The product is supplied by MB PHARMA S.R.O. and has no marketing authorisation in the product records, meaning it remains an investigational substance.^[2][1]

Table of contents

• What is DUOFAG?
• How does DUOFAG work?
• Which conditions is DUOFAG being studied for?
• How is DUOFAG given?
• What do the clinical trials show?
• Who can take part in these trials?
• What side effects are known?

What is DUOFAG?

Bacteriophages are viruses that infect and kill specific bacteria. The therapeutic area of the product records places it in bacterial infections and mycoses as well as skin and connective tissue diseases.^[2][1]

How does DUOFAG work?

DUOFAG contains three bacteriophages that target Staphylococcus aureus and Pseudomonas aeruginosa. Bacteriophages attach to specific bacterial cells and destroy them, which is expected to reduce or eliminate the bacterial colonisation of infected wounds. The two Kayvirus phages target S. aureus, while the Pbunavirus phage targets P. aeruginosa. The trials measure whether this leads to eradication of the bacteria from wound swabs and whether wound healing begins.^[2][1]

Which conditions is DUOFAG being studied for?

• Surgical wound infection or dehiscence caused by colonisation with S. aureus and/or P. aeruginosa — studied in the Phase 1/2 trial.^[2]
• Complicated skin wounds, including infected surgical or traumatic wounds healing by granulation tissue (secondary intention) and chronic wounds, in both cases infected with S. aureus and/or P. aeruginosa — studied in the Phase 4 trial.^[1]

How is DUOFAG given?

DUOFAG is formulated as a cutaneous solution and is applied topically directly onto the wound surface. In the Phase 4 trial, the dose is reported as 50,000,000,000 plaque-forming units (PFU) applied to the wound.^[1] In both trials, the comparison arm receives a 0.9% sodium chloride infusion solution applied topically to the wound.^[2][1]

What do the clinical trials show?

Two clinical trials of DUOFAG are authorised in the EU Clinical Trials Information System and on ClinicalTrials.gov. Both are interventional studies. The first is a Phase 1/2 trial with 52 participants, authorised and listed on ClinicalTrials.gov under NCT06319235. The second is a Phase 4 trial with 100 participants, authorised and registered under EU CT number 2025-522752-45-00.^[2][1]

The Phase 1/2 trial has two cohorts. For Cohort 1, the primary outcome is the frequency of all local and systemic reactions with suspected or confirmed relation to the investigational medicinal product. For pooled Cohorts 1 and 2, the primary outcome is time to commencement of healing, defined as a composite measure: the granulation process in the wound has started, indicated by a score of 2 or less in each of three items (A8–A10) of the mLUMT scale, and the S. aureus and/or P. aeruginosa infection has been eradicated, meaning the wound swab is negative for both bacteria.^[2]

The Phase 4 trial measures safety as the frequency of all serious local and systemic adverse reactions and events suspected or confirmed to be related to the investigational medicinal product during the 14-day application phase. Its efficacy outcomes are the presence of S. aureus and/or P. aeruginosa colonies on wound swabs during the application period and the number of such colonies on wound swabs over the same period. The stated objective is to demonstrate reduction or complete eradication of the bacteria during 14 days of application, evaluated by wound swab and stamp examination.^[1]

Who can take part in these trials?

The Phase 1/2 trial enrols participants with surgical wound infection or dehiscence caused by colonisation with S. aureus and/or P. aeruginosa.^[2] The Phase 4 trial enrols participants with complicated skin wounds, either as a complication of healing of acute wounds (infected surgical or traumatic wounds) or chronic wounds, in both cases infected with S. aureus and/or P. aeruginosa.^[1] Detailed inclusion and exclusion criteria are available in the registry records.

What side effects are known?

The safety of DUOFAG is the primary focus of both trials. The Phase 1/2 trial measures the frequency of all local and systemic reactions with suspected or confirmed relation to the investigational medicinal product.^[2] The Phase 4 trial measures the frequency of all serious local and systemic adverse reactions and events suspected or confirmed to be related to the investigational medicinal product during the 14-day application phase.^[1] No side effect data from completed studies are provided in the registry records.