Support for SME Instruments phase 1 application: NOVEL MARINE ANTI-INTERLEUKIN-1 BETA WOUND PATCH

Regenics has from Nov 2015 worked under a co-development agreement with one of the top 5 global wound healing companies to explore Regenics wound closure bioactive HTX. HTX is a patented purified component of unfertilized salmon roe cytoplasma with anti-IL-1b activity. HTX was selected to this collaboration based on 2 key findings: accelerated wound closure in human skin explants (Heldrup, et al. 2015) and a novel mechanism of action: potent IL-1b inhibitory effect on human macrophages (unpublished data). Increased IL-1b is a hallmark for skin inflammation in chronic and acute wounds, but also in autoimmune inflammatory skin diseases like psoriasis and atopic dermatitis. A topical immunomodulating wound closure accelerator will be a first in class product. HTX has a complete pre-clinical dossier, animal safety/toxicity studies, human skin proof of principle studies and topical safety studies in humans. Selection of HTX by the global company as a candidate for inclusion in a bioactive patch represents for Regenics a unique license opportunity for our technology to one of the world's largest companies. It also reduces the regulatory and commercial realization hurdle of the project for a small SME as the target devices, to which HTX is to be included, are already on the market with a very strong existing commercial footprint. The principal scope of the present feasibility SME 1 application is to outline a critical wet to dry chemistry transition for HTX (HTX is in aqueous format at present) into the partners "dry chemical" sterile production line. We also have recently obtained an EPO patent (EP20070825530, 2017) for a 95°C heating step in purification of HTX. Full clinical testing of the HTX integrated patch in a human clinical chronic wound model, preferably in diabetes patients, will be included in the subsequent SME Inst 2 application, including a fully costed medical device clinical development for a class III, rule 13 label for the HTX integrated final device.