A feasibility study on the development of Psorax35 as the first and only oral treatment for mild-to-moderate psoriasis with positive effects on co-morbidities.

A feasibility study on the development of Psorax35 as the first and only oral treatment for mild-to-moderate psoriasis with positive effects on co-morbidities.

The objective of the main project is to commercialize Psorax35 – the first oral medicine for mild to moderate psoriasis with positive effect on comorbidities. Current psoriasis medicines have limited efficacy, serious side effects and waning effect over time. According to WHO there is a global need for new safe, tolerable, effective and convenient psoriasis medicines that can be given without close monitoring by health personnel. Developing and documenting Psorax35 as an efficacious treatment of mild and moderate psoriasis will lay the foundation for further investigations in severe psoriasis. Comorbidities like cardiovascular disease and arthritis will most probably be positively affected by Psorax35 and add to the value of the product. If Psorax35 is shown to be effective, psoriasis patients will experience better quality of life, and society will benefit from reduced direct medical expenses and increased working capability of many patients today suffering from psoriasis. It will also enable Arctic Nutrition AS to create a growing business and have the ability to further expand and create new jobs. 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 feasibility), strategic innovation funding (grant screening) as well as further screening of potential marketing partners