Synthesis of API, development of formulation and in vivo studies of a cream containing human gut microbiota postbiotic metabolite – U228 for topical treatment of atopic dermatitis
project manager: dr hab. Jakub Piwowarski;
investigator: dr Barbara Żyżyńska-Granica
Atopic dermatitis (AD) is the most common chronic skin condition reported to affect 15–20% of children and 1–3% of adults. Since the 1970s, the incidence of atopic dermatitis has increased 2- to 3-fold in industrialised countries. Currently, there is no cure for AD, and treatment is focused on alleviating the debilitating signs and symptoms and gaining control over recurrent flares. The moderate therapeutic efficacy of available drugs, significant side effects and high percantage of patients dissatisfied with their AD treatment clearly indicate the need of new therapies development.
Urolitin A (U228) is a postbiotic metabolite produced by human gut microbiota from compounds found in certain food products. In vitro studies conducted by PI have shown for U228 strong anti-inflammatory activities depending on inhibition of p65 NFkappaB nuclear translocation. Subsequent in vivo studies confirmed the anti-inflammatory properties on skin following topical administration of U228.
The planned R&D works will include scaling of U228 synthesis together with delivery of the substance as well as development of topical formulation (FU228), for which physicochemical and pharmaceutical studies will be conducted. New formulation will be tested towards the anti-inflammatory activity on the in vivo animal model. The foreseen activities will provide API and topical formulation, which are necessary starting point for pre-clinical studies. In vivo studies will confirm the anti-inflammatory activity of FU228 and will identify additional molecular targets responsible for the observed effects. Basing on the obtained results, a Drug Development Plan and a Business Plan will be developed, which will be presented during meetings with potential investors.
Further R&D works including subsequent phases of pre-clinical and clinical research will be conducted within the established spin-off company with the contribution of an investor from the biomedical field.