New Positive Phase 2 Interim Analysis Confirms Efficacy of denovoSkin for Reconstructive Skin Surgery

denovoSkin | Image provided by Cutiss

Cutiss recently announced new positive interim analysis data on the efficacy of its phase 2 trial evaluating denovoSkin in pediatric, adolescent, and adult patients in need of reconstructive skin surgery due to various conditions. Cutiss, a Switzerland-based company, expects to have full phase 2 data with one year follow-up in early 2025.¹

DenovoSkin is a personalized human skin graft that can be bio-engineered in large quantities to grow with the patient’s healing skin. According to Cutiss, “It aims to significantly reduce the need for healthy skin harvesting, significantly reduce scarring, as well as reduce the need for follow-up corrective surgeries.”

In total, 23 patients are enrolled in the multicenter phase 2 trial. The trial focuses on conditions that require skin grafts, such as scars, traumatic injuries, congenital defects, surgical excisions, and more, and aims to provide solutions that reduce scarring and improve healing outcomes.

“We are thrilled with this first positive assessment of efficacy from the Phase 2 trial in reconstructive surgery. These results confirm Cutiss’s mission to provide access to denovoSkin beyond burns, improve patient outcomes, and change the status quo in skin surgery,” said Daniela Marino, CEO of Cutiss, in the news release.

DenovoSkin is also currently in clinical trials for the treatment of adults and adolescents with severe burns. 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. The phase 1 study assessed the safety of the product in children and adults who received skin transplantation due to acute burns or reconstructive surgeries. An area of the wounds on the patients were treated with a maximum of one denovoSkin graft. The study confirmed the denovoSkin’s safety in its first-in-human clinical trial.²

After the success of the phase 1 trial, denovoSkin’s safety and efficacy were evaluated in 3 parallel phase 2 clinical trials for burns. Although the trials were similar in design, their patient populations and indications differed. In all 3 phase 2 trials, denovoSkin was compared to today’s current standard of care of the transplantation of autologous split-thickness skin. In the trials, 2 comparable wound areas were selected and were treated with either one denovoSkin graft or one autologous split-thickness skin graft. During the trials, the 2 wound areas were analyzed and compared over a span of 3 years. Once the efficacy of denovoSkin for burns is confirmed in the phase 2 clinical trials, phase 3 will be initiated.²

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

“Cutiss is really committed to make sure that this product, once on the market, will be accessible. We have been working for the last 6 years on a unique innovative automation platform for the manufacturing of the product in a decentralized and close to point of care in a situation so that we can really lower the cost, increase robustness, and make sure that the product once proven safe and efficacious, can actually be accessible for the patients and the professionals which will be able to use it in routine,” said Marino in a previous interview with Dermatology Times.

References

1. Reconstructive skin surgery: positive phase 2 interim analysis on efficacy for denovoSkinin pediatric, adolescent and adult patients. News release. Cutiss. July 9, 2024. Accessed July 10, 2024. https://cutiss.swiss/reconstructive-skin-surgery-positive-phase-2-interim-analysis-on-efficacy-for-denovoskin-in-pediatric-adolescent-and-adult-patients/
2. Clinical development program. Cutiss. Accessed July 10, 2024. https://cutiss.swiss/clinical-problem-scars/
3. Cutiss announces results from phase 2 clinical trials for denovoSkin in adolescent and adult burn patients, and phase 1 in children. Cutiss. Published April 3, 2023. Accessed July 10, 2024. https://cutiss.swiss/cutiss-announces-positive-phase-2-clinical-trial-results-for-denovoskin/