A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. Cutiss, a spin-off of the University of Zurich, developing personalised skin graft technologies for the treatment of a large spectrum of skin defects, has received a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) for its proposed PIP for the denovoSkin.
The positive opinion is based on the non-clinical program, as well as data from the phase I safety clinical trial and the plans for the current phase IIb efficacy trials running in children and adults. The PDCO’s positive opinion on CUTISS’ PIP endorsed the company’s program for denovoSkin as acceptable for assessment of safety and efficacy for the use in children from birth to less than 18 years of age.
CUTISS has been developing a personalised, biotechnological skin transplantation products for the treatment of burns, skin defects and extensive scar corrections. The lead product, denovoSkin, has already received Orphan Drug Designation by Swissmedic, EMA and FDA. Based on 15 years of research, Cutiss can now bio-engineer large quantities of individually customised human skin grafts at a ratio of 1:100.
To this end, Cutiss has completed Phase I in pediatric patients at the University Children’s Hospital in Zurich and Phase II clinical trials are currently underway in Europe (Italy) and Switzerland. The startup expects to complete the studies by 2022, after which it anticipates to generate the first sales in 2022/2023 in Europe. The global market for extensive burns is USD 10bn USD 2bn in Europe and the United States.
While the product continuously proves its potential and delivers promising results, the startup and its team of 20 members are working on an automated serial Good-Manufacturing-Practice (GMP) production to scale-up production. The automated production system is being developed in collaboration with Zühlke Engineering andCSEM, supported by H2020 EU and Innosuisse grants. The first prototype is expected by Q4 2020.