API synthesis, formulation development and in vivo testing for a cream containing a postbiotic metabolite of human intestinal microbiota - U228 for spot application in the treatment of atopic skin inflammations
mikrobioty jelitowej człowieka – U228 do stosowania miejscowego w terapii atopowych stanów zapalnych skóry
Atopic dermatitis (AD) is the most common chronic skin disease, affecting 15-20% of children and 1-3% of adults. Since the 1970s, the incidence of atopic dermatitis has increased two to three times, especially in industrialized countries.
There is currently no effective treatment for complete remission of AD, and treatments are focused on relieving symptoms and gaining relapse control. The moderate therapeutic efficacy of the available drugs, significant side effects and patient satisfaction data clearly demonstrate the need to develop new therapies. Urolithin A (U228) is a postbiotic metabolite produced by the human gut microbiota from compounds found in some food products, for which PI in vitro showed strong anti-inflammatory properties due to inhibition of the translocation of the NFkappaB p65 subunit into the cell nucleus. In vivo studies performed confirmed the anti-inflammatory activity on the skin after topical administration of the compound.
The planned R&D works will include scaling the synthesis of U228 and delivering the substance, developing a semi-liquid formulation (FU228), conducting physicochemical and pharmaceutical tests for it, and testing the anti-inflammatory activity of FU228 on an in vivo model. The above work will provide the API and formulation that are necessary to start preclinical research. In vivo studies will confirm the anti-inflammatory activity of FU228 and indicate additional molecular mechanisms responsible for it. Based on the results of the application research, a Drug Development Plan and a business plan will be prepared, which will be presented during talks with potential investors.