Project description
Next-generation topical medication for the treatment of eczema
Atopic dermatitis, or eczema, is a chronic skin condition that is common in children but may occur at any age. It arises as a result of a complex interaction between genetic and environmental factors and poses a significant burden on patients’ quality of life. Itch is an enormous, unresolved symptom in atopic dermatitis, induced by inflammation and skin damage. Sweden's TIRmed Pharma AB has developed a non-steroid cream to resolve itch with topical application. The medication targets mild to moderate symptoms, has an excellent safety profile and is affordable and easy to self-apply. Moreover, as the solution interferes with the immune system in a selective manner, it dampens inflammation. The EU-funded TIR-C project proposes a feasibility study, the development of a commercialisation plan and the confirmation of the regulatory requirements needed for market approvals.
Objective
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.
Fields of science
- 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)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
16753 BROMMA
Sweden
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.