Carbiotix AB (publ) announced that the Company has achieved regulatory approval for CarbiAXOS based on corn bran as a cosmetic ingredient. This marks the first regulatory approval for CarbiAXOS as a prebiotic ingredient, demonstrating the general safety of the product. The approval process, similar to GRAS SA, was achieved through a self-affirmation process with the assistance of a third-party regulatory consultant in the drafting of a safety dossier.

This approval now opens the door to commercial activities with regards to ramping up of sales activities, the production of samples suitable for customer formulation activities, and accelerating next generation prebiotic development activities. Additionally, Carbiotix can now leverage its production of a cosmetic ingredient at the facility in Bjuv for global sales and distribution, optimizing the production investments previously made in the facility. Prebiotics are increasingly being used in topical (wash-on /wash-off) applications as a means to improve the health of the skin microbiome.

Thus, a skin prebiotic ingredient can be used for general cosmetic applications as well as potentially an adjuvant with topical therapeutics to address skin related diseases. Moreover, a skin prebiotic ingredient can be delivered together with probiotics and postbiotics in the form of a synbiotic product. Regardless of the application, the efficacy of the prebiotic is a key factor impacting its use, application, and value as a prebiotic.

CarbiAXOS has been designed to be a best in class effective prebiotic that is not only suitable for nutraceutical applications but also cosmetic applications. Moreover, like nutraceutical applications, the efficacy of CarbiAXOS for cosmetic applications can be validated using the LinkGut microbiome companion diagnostic platform. The global market for cosmetic prebiotic ingredients is estimated to be roughly 10% of the 1 Billion Euro high-end prebiotic ingredients market Carbiotix is targeting, with nutraceutical applications representing the other 90% of the market.

CarbiAXOS has gone through several development iterations over the past three years to improve the efficacy and suitability of the product for different applications, the time to market, as well as the cost, flexibility, and environmental impact of the manufacturing process. From using an in-house production enzyme, to using a third-party enzyme and finally an iteration where the use of an enzyme is optional; this development process has resulted in new CarbiAXOS products and processes with each iteration impacting the regulatory process. Although, CarbiAXOS will continue to be improved over time, the Company is now pursuing the regulatory approval of the current generation of CarbiAXOS as a nutraceutical and cosmetic ingredient to demonstrate its general safety.