E!9477 Development of wound healing device with salmon roe wound healing ingredient

Regenics AS is an Oslo-based Norwegian biotech company with focus developing wound healing products based on bioactive substances from salmon roe. Regenics' researchers have shown that extracts from fish eggs can redirect differentiated cells to display altered function, morphology and gene expression. Regenics has preclinically tested the salmon roe fraction and characterized components. We have found a heat stable fraction with equal or even higher biological activity. This fraction is easier to formulate, show better stability, can be sterile-filtered and has shown to completely reepithelialize burn wounds, demonstrated in an ex vivo wound healing study of transplanted skin. In this study, we showed that in an ex vivo human skin model the salmon roe extract promotes healing of burn wound both in optimal wounding conditions (10% serum) and in sub-optimal conditions. The burn wounds treated with the salmon roe fraction healed completely, while the control was not completely healed at the end of the experiment. These results were presented at the ETRS-WHS conference in Copenhagen October 2015. Consortium partner SP has in close collaboration with Regenics investigated several formulations suitable for the salmon roe extract; a formulation with the sterile-filtered salmon roe bioactive fraction has been locked for the oral wound care device. Clinical safety study on human intact skin is completed; with no adverse events to the device (gel with salmon roe extract) as well as a pilot clinical trial on burn wounds with the salmon roe extract (no adverse events). A clinical safety study on induced second degree wounds in human volunteers has been approved by the ethical Regional Committees for Medical and Health Research Ethics. Regenics has initiated collaboration with contract manufacturer Curida for production of medical device for clinical studies to meet the requirements in the Medical Device Directive. Finally, as a result of Regenics wound healing research, a collaboration with world-leading wound healing company has been initiated; the collaboration partner has delivered very promising results with the heat stable salmon roe fraction; the salmon roe fraction was shown to inhibit IL-1b production/secretion in a human monocyte/ INF-y/LPS-induced macrophage assay. The partner observed that IL-1 b inhibitory effect of the salmon roe fraction is superior to the positive control IL-4; which inhibits IL-1b signaling in this assay. Due to the positive results, the R&D collaboration will thus continue.

The goal of this project is to develop a completely safe medical device accelerating wound healing. We will in Collaboration with SP formulate a vehicle for release of the biologically active marine salmon roe extract to a breached surface. The project will attempt to clinically prove previous research by Regenics, showing that reprogramming of differentiated cells by cellular extract in vitro, translates into a meaningful disease modification in a clinical model (Collas et al, Nature). The project will deliver results from two clinical phase II studies with the final product, which will support preclinical experiments; roe extracts has the ability to promote core processes in wound biorepair, and establish that marine biomolecules can interact with human tissue surfaces/cells to create clinically relevant wound healing. The results of the clinical phase II will support claim generation of the final product. The final device will be marketed through a global launch with a major pharma or graded consumer goods partner.