KAYVIRUS DSM 33474

What does this page cover?

• Which conditions is it studied for?
• What do the clinical trials show?
• What side effects are known?

What is KAYVIRUS DSM 33474?

and has no marketing authorisation in the product records, meaning it is still an investigational substance.^[2] Kayvirus phages are obligatorily lytic, meaning they always destroy the bacterial cells they infect.^[3]

How does KAYVIRUS DSM 33474 work?

Kayvirus bacteriophages attach to the surface of Staphylococcus aureus bacteria, inject their genetic material, and force the bacterial cell to produce new phage particles until the cell bursts. This lytic cycle kills the bacterium directly.^[3] Kayviruses infect and kill the majority of S.

Which conditions is it studied for?

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

The therapeutic area covers bacterial infections and skin and connective tissue diseases.^[2]

How is KAYVIRUS DSM 33474 given?

DUOFAG is a cutaneous solution for topical application on wounds.^[2] In the Phase 4 trial, the product is applied at a dose of 50,000,000,000 PFU (plaque-forming units, a measure of active phage particles) per application, while the comparison arm receives 1 ml of physiological saline solution topically.^[1]

What do the clinical trials show?

Two authorised, interventional trials are registered for DUOFAG. The Phase 1/2 trial (NCT06319235) enrolled 52 participants with surgical wound infection or dehiscence caused by S. aureus and/or P. aeruginosa colonisation.^[2] Its primary objective is to demonstrate safety plus clinical and microbiological change within 10 weeks after the start of treatment or until healing. For the first cohort, the main measure is the frequency of all local and systemic reactions with suspected or confirmed relation to the investigational medicinal product. For pooled cohorts, the main measure is time to commencement of healing, defined as a granulation score of 2 or less on three items of the mLUMT scale and a negative wound swab for both S. aureus and P. aeruginosa.^[2]

The Phase 4 trial (2025-522752-45-00) enrolled 100 participants with complicated skin wounds infected with S. aureus and/or P. aeruginosa.^[1] It measures safety as the frequency of all serious local and systemic adverse reactions suspected or confirmed to be related to the product during the 14-day application phase, and efficacy as the presence and number of S. aureus and/or P. aeruginosa colonies on wound swabs during the same period.^[1]

What side effects are known?

The registered trials are designed to measure safety outcomes, including local and systemic reactions with suspected or confirmed relation to the product.^[2][1] The supplementary source notes that bacteriophages of the Kayvirus genus are harmless to humans, animals and plants, and have been used in experimental therapies of staphylococcal infections in humans and animals.^[3] No specific side-effect frequencies are reported in the available sources.