Descrizione del progetto
Sviluppo del primo trattamento orale per la psoriasi lieve e moderata
Secondo l’Organizzazione mondiale della sanità, si avverte l’urgenza di un farmaco per la psoriasi efficace e sicuro, utilizzabile senza la necessità di un attento monitoraggio del paziente. I farmaci disponibili non hanno un’efficacia soddisfacente e spesso causano gravi effetti collaterali. Il progetto PsoraxPlan, finanziato dall’UE, mira a sviluppare e distribuire Psorax35 come farmaco efficace per i casi lievi e moderati di psoriasi. Se Psorax35 si dimostrasse efficace contro la psoriasi, potrebbe anche avere un effetto positivo su comorbilità quali l’artrite e le complicanze cardiovascolari. L’obiettivo della prima fase dell’intero progetto è quello di fornire un’analisi di fattibilità completa di questo farmaco per il trattamento della psoriasi lieve e moderata.
Obiettivo
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
Campo scientifico
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-1
Meccanismo di finanziamento
SME-1 - SME instrument phase 1Coordinatore
6155 ORSTA
Norvegia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.