Description du projet
Médicaments topiques de nouvelle génération pour le traitement de l’eczéma
La dermatite atopique, ou eczéma, est une affection cutanée chronique commune chez les enfants, mais qui peut se manifester à tout âge. Elle résulte d’une interaction complexe entre des facteurs génétiques et environnementaux et représente une charge importante sur la qualité de vie des patients. La démangeaison est un énorme symptôme non résolu de la dermatite atopique, induite par l’inflammation et les lésions cutanées. La société suédoise TIRmed Pharma AB a mis au point une crème non stéroïdienne pour traiter les démangeaisons par application topique. Le médicament cible les symptômes légers à modérés, présente un excellent profil d’innocuité et est abordable et facile à appliquer soi-même. De plus, étant donné que la solution interfère avec le système immunitaire de manière sélective, elle atténue l’inflammation. Le projet TIR-C financé par l’UE propose une étude de faisabilité, l’élaboration d’un plan de commercialisation et la validation des exigences réglementaires nécessaires à l’autorisation de mise sur le marché.
Objectif
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.
Champ scientifique
- 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
Programme(s)
Régime de financement
SME-1 - SME instrument phase 1Coordinateur
16753 BROMMA
Suède
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.