A feasibility study on the development of Psorax35 as the first oral treatment for mild-to-moderate psoriasis

The objective of the PsoraxPlan feasibility study is to deliver a comprehensive feasibility analysis of the development of Psorax35 as a medicinal product for the global market to treat mild-to-moderate psoriasis. The feasibility analysis will include a thorough assessment of technical, regulatory, market access, and financing feasibility including a risk analysis and risk mitigation plan. Of particular importance are the specific feasibility analyses on aspects related to regulatory affairs (systematic review of the literature for omega-3 in the treatment of psoriasis; initial outlining of the clinical development plan; and outline for scientific advice meetings with regulatory authorities), clinical development (protocol outlines, budgets and site/patient recruitment feasibility), strategic innovation funding (grant screening) as well as further screening of potential marketing partners. Specific tasks subcontracted during feasibility analysis: (i)Systematic literature review on the use of omega-3 in the treatment of psoriasis; (ii) Drafting protocol outlines, associated budgets, timelines and site feasibility analyses for the phase 2b and phase 3 clinical trial; (iii) Develop a strategic innovation funding plan; i.e. a comprehensive analysis and report on potential non-dilutive R&D grants eligible for the Psorax35 project, and (iv) Participate in the planning and conduct of scientific advice meetings with EMA and the FDA.