New Positive Phase 1 & 2 Results of DenovoSkin for Burns

Photo courtesy of Cutiss AG

Cutiss AG, a clinical-stage life sciences company based in Switzerland dedicated to tissue regeneration and engineering, recently announced positive results from its phase 2 clinical trial evaluating denovoSkin in adults and adolescents with severe burns.¹ Cutiss’ phase 1 trial recently completed a 5-year follow up and demonstrated product safety among pediatric and adolescent patients during burns and reconstructive surgeries. DenovoSkin is a personalized skin graft that grows with each patient to limit scarring and corrective surgeries.

The first phase 2, prospective, intra-patient randomized controlled, multicenter study evaluating burns is designed to investigate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute for the treatment of partial deep dermal and full thickness burns in adult patients compared to autologous split-thickness skin grafts. DenovoSkinis a transplant product made from a patient’s skin using the transplantation of a thin autologous skin graft (split-thickness skin graft). Two burned areas of skin that require a skin graft are randomly selected to be treated with denovoSkinand or the patient’s skin. Following treatment, both grafts are monitored for safety and efficacy.²

An additional phase 2 trial is evaluating the safety and efficacy of denovoSkin among pediatric patients aged 12 years or younger who need a skin graft due to severe burns. Cutiss’ final regenerative skin trial is a phase 2, prospective, intra-patient randomized controlled, multicenter study designed to examine and compare the safety and efficacy of denovoSkin made from a patient’s own skin with the transplantation of a split-thickness skin graft in patients who need a skin graft due to reconstructive surgery. Patients eligible for the skin graft may have recently experienced the removal of a scar, congenital nevus, benign skin tumor, or recently had gender reassignment surgery.²

Cutiss noted that a full data analysis of the phase 2 trials with a 3-year follow up will be available in 2025, as the last patient transplant occurred in August 2022. Additionally, denovoSkin has received Orphan Drug Designation for the treatment of burns from Swissmedic, the European Medicines Agency, and the US Food and Drug Administration.

References

1. Cutiss announces results from phase 2 clinical trials for denovoSkin in adolescent and adult burn patients, and phase 1 in children. Cutiss AG. Published April 3, 2023. Accessed April 4, 2023. https://cutiss.swiss/cutiss-announces-positive-phase-2-clinical-trial-results-for-denovoskin/
2. Clinical problem scars. Cutiss AG. Accessed April 4, 2023. https://cutiss.swiss/clinical-problem-scars/