Descrizione del progetto
Farmaco per uso topico di nuova generazione per il trattamento dell’eczema
La dermatite atopica, o eczema, è una condizione cronica della pelle comune nei bambini, ma può manifestarsi a qualsiasi età. Insorge come risultato di una complessa interazione tra fattori genetici e ambientali e rappresenta un onere significativo per la qualità della vita dei pazienti. Nella dermatite atopica, il prurito è un sintomo grave e irrisolto, indotto da infiammazione e danno cutaneo. La svedese TIRmed Pharma AB ha sviluppato una crema non steroidea per combattere il prurito con applicazioni topiche. Il farmaco è indicato per sintomi da lievi a moderati, ha un eccellente profilo di sicurezza ed è economico e di facile auto-applicazione. Inoltre, poiché la soluzione interferisce in modo selettivo con il sistema immunitario, attenua l’infiammazione. Il progetto TIR-C, finanziato dall’UE, propone uno studio di fattibilità, lo sviluppo di un piano di commercializzazione e la conferma dei requisiti normativi necessari per l’approvazione del mercato.
Obiettivo
TIRmed pharma AB has developed a non-steroid cream that relives itch in Atopic Dermatitis (AD). Itch is an enormous, unresolved symptom in AD, induced by inflammation and skin damage. AD poses a significant burden on societies and patients’ quality of life due to itch, infected lesions, sleep deprivation, and consequently productivity loss, psychological health and treatment-associated expenditures. Persons affected by AD consistently rate AD management to be comparable to diabetes management. Our TIR-C cream doesn’t contain steroids and works through an entirely novel mechanism of action. The therapy has been developed with the largest patient group in mind; children. TIR-C has the potential to become a blockbuster in AD management as it has an excellent safety profile, is very affordable, is easy to self-apply (water-based), doesn’t interfere with vital immune defences and has the potential to prevent disease escalation. We target mild-to-moderate symptoms (80% of all AD sufferers), aiming to eliminate the need for intravenously administrated biologics. Biologics are not only extremely costly, but also associated with severe side effects, making them unsuitable for children.
The unmet need for safe, topical anti-itch-treatment in persons with mild-to-moderate AD has been clearly communicated by leading contract research organizations, KOLs and clinicians within dermatology. TIR-C is at Technology Readiness Level 4 with established manufacturing and formulation processes and a clinical development plan drafted in collaboration with a leading CRO in dermatology. The proposed feasibility study will advance preparations for commercialisation by allowing us to confirm regulatory requirements needed for market approvals, validate pricing through a health-economic survey in the EU, identify a local CRO to conduct the planned phase I/IIa clinical trials and confirm Freedom to Operate.
Campo scientifico
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesclinical medicinedermatology
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesbasic medicineimmunology
- social scienceseconomics and businesseconomicsproduction economicsproductivity
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
16753 BROMMA
Svezia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.