PBUNAVIRUS DSM 33593

Table of contents

• Which conditions is it studied for?
• What do the clinical trials show?
• Who can take part in these trials?
• What side effects are known?

What is Pbunavirus DSM 33593?

How does Pbunavirus DSM 33593 work?

The trials focus on wounds colonised or infected with Staphylococcus aureus and Pseudomonas aeruginosa. The primary outcomes measure whether the treatment reduces the presence of these bacteria or achieves complete eradication from wound swabs.^[1] The mechanism relies on the phage recognising and infecting the target bacteria, which is expected to reduce the bacterial load in the wound.

Which conditions is it studied for?

• Surgical wound infection/dehiscence caused by S. aureus and/or P. aeruginosa colonisation — studied in the Phase 1/2 trial.^[2]
• Complicated skin wounds healing per secundam — including infected surgical or traumatic wounds and chronic wounds, all infected with S. aureus and/or P. aeruginosa — studied in the Phase 4 trial.^[1]

How is Pbunavirus DSM 33593 given?

DUOFAG is a cutaneous solution applied topically on the wound.^[2] In the Phase 4 trial, the dosage is reported as 50,000,000,000 PFU (plaque forming units) per application, applied topically on the wound.^[1] The Phase 1/2 trial does not report a specific dose.^[2]

What do the clinical trials show?

Two interventional trials are registered for DUOFAG, both authorised. The Phase 1/2 trial (NCT06319235) is evaluating safety and the time to commencement of wound healing in 52 participants over up to 10 weeks.^[2] The primary endpoint for cohort 1 is the frequency of local and systemic reactions related to the investigational product; for pooled cohorts 1 and 2, it is the time to commencement of healing, defined as granulation tissue starting and eradication of S. aureus and/or P. aeruginosa.^[2]

The Phase 4 trial (2025-522752-45-00) is studying safety and efficacy in 100 participants with complicated skin wounds.^[1] The primary outcomes include the frequency of serious adverse reactions during 14 days of application, and the presence and number of S. aureus and/or P. aeruginosa colonies on wound swabs over the application period.^[1]

The comparator in both trials is a 0.9% sodium chloride solution applied topically.^[2][1]

Who can take part in these trials?

The Phase 1/2 trial includes participants with surgical wound infection or dehiscence caused by S. aureus and/or P. aeruginosa colonisation.^[2] The Phase 4 trial includes participants with complicated skin wounds healing per secundam, either as a complication of acute wounds or as chronic wounds, in both cases infected with S. aureus and/or P. aeruginosa.^[1]

What side effects are known?

The registered trials measure safety outcomes. The Phase 1/2 trial records the frequency of all local and systemic reactions with suspected or confirmed relation to the investigational product.^[2] The Phase 4 trial records the frequency of all serious local and systemic adverse reactions and events suspected or confirmed to be related to the product during the 14-day application phase.^[1] Detailed side effect data are not yet available in the registry records.