Arctic Bioscience is one of 5 Norwegian companies who were granted SME Instrument funding in 2019, of 283 projects in the EU. The grant was awarded by the European Innovation Council for developing a business plan for a new drug to treat psoriasis.
The project “PsoraxPlan” is 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 PsoraxPlan was to deliver a comprehensive feasibility analysis of the development of HRO350 (formerly named Psorax35) as a medicinal product for the global market to treat mild-to-moderate psoriasis. The feasibility analysis included a thorough assessment of technical, regulatory, market access, and financing feasibility including a risk analysis and risk mitigation plan; esp. a specific feasibility analysis on aspects related to regulatory affairs (systematic review of the literature; outlining the clinical development plan; and the scientific advice meetings with regulatory authorities), clinical development (protocol outlines, budgets, and patient recruitment feasibility), strategic innovation funding (grant screening) as well as further screening of potential marketing partners.
The analysis has provided very useful and thorough data to enable the company’s board to make essential decisions regarding the business idea. As a result of the analysis, nothing material has changed in the objectives, concept, and approach compared to the strategic plan we had prior to the feasibility analysis. However, the analysis has further strengthened the grounds for investing in the undertaking and made such decision-making more robust; concluding that the HCO350 drug development project shall continue. The only adjustments include (i) more details have emerged for the clinical development plan, providing us with a series of different study designs that will be presented and discussed in the upcoming informal and formal scientific advice meetings; (ii) the regulatory affairs feasibility demonstrated that there are several ways to define the active substance and that the way forward will depend very much on the mutual agreement with relevant regulatory authorities: mechanism of action theories will be investigated by measuring alterations in cytokine profiles, testing in a 3D psoriatic skin model; (iii) In order to reach the stage where a global licensing deal can be obtained with ‘big pharma’ partners, we will have to attract expertise, and several technical development partners and subcontractors, as well a number of potential marketing partners, were identified in the feasibility process.