EU gives the green light to Cutiss study in children

Cutiss is seeking to make personalized skin tissue therapy, which is developed with the help of automated technology, available on the market. Its product candidate denovoSkin aims to help adults and children alike suffering from profound skin defects that cover a large area. Cutiss has now received a positive response to its request to conduct a more comprehensive pediatric investigation plan (PIP) from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA)

The PCDO has evaluated the denovoSkin therapy for children from birth right through to adulthood as sufficiently safe and effective. The basis for this positive assessment is data from the non-clinical program, a clinical Phase I safety study and the plans for the ongoing Phase IIb efficacy studies, which are being conducted on both children and adults.

A PIP is designed to guarantee that the data required for authorization of a drug also intended for use in children can be obtained from clinical trials on pediatric patients.

Cutiss is a spin-off from the University of Zurich (UZH). The company is headquartered in Zurich and operates research facilities at Bio-Technopark Schlieren-Zurich. Its leading product candidate denovoSkin has been tested as part of a clinical Phase I study at the University Hospital of Zurich on young patients. It was well tolerated by all patients, while no safety issues arose either. At the moment, Phase II studies are being conducted in Switzerland and the European Union, which are being partly financed by Wyss Zürich.

DenovoSkin has been awarded Orphan Drug Designation by Swissmedic, the European Medicines Agency and the FDA, the regulatory authority in the USA for the treatment of burns. In addition, denovoSkin is aims to improve the quality of life of patients by way of reconstructive treatments.