NEXT GENERATION TOPICAL MEDICATION TO TREAT IMMUNE RESPONSES IN ATOPIC DERMATITIS – THE MOST COMMON CAUSE OF ECZEMA

Project Information

TIR-C

Grant agreement ID: 885787

DOI

10.3030/885787

Project closed

EC signature date 29 November 2019

Start date 1 December 2019

End date 31 May 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

TIRMED PHARMA AB
Sweden

Periodic Reporting for period 1 - TIR-C (NEXT GENERATION TOPICAL MEDICATION TO TREAT IMMUNE RESPONSES IN ATOPIC DERMATITIS – THE MOST COMMON CAUSE OF ECZEMA)

Reporting period: 2019-12-01 to 2020-05-31

Summary of the context and overall objectives of the project

Atopic Dermatitis (AD) is one of the most common chronic skin diseases. The prevalence of AD has shown 3x growth in the last 30 years, currently affecting 10-20% of children and 3-5% adults globally. AD poses a huge 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. Allergic sensitization from AD, known as "the atopic march", can lead to the development of chronic asthma and rhinitis, reducing expected life quality among patients. Current products on the market have significant side effects, with only temporary symptom reduction. The Economic impact of AD due to productivity losses, sick leaves, and medical costs is estimated to be over 5 B USD in the USA alone.

TIRmed Pharma AB has developed a non-steroid cream that relieves inflammation and itch in AD. Our TIR-C cream 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. Moreover, is affordable, easy to self-apply (water-based), doesn’t interfere with vital immune defences and has the potential to prevent disease escalation.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The feasibility study allowed us to advance the preparations for commercialisation and confirm the regulatory requirements needed for market approvals. Through the assessment of the pre-clinical and technical feasibility, we have designed the toxicology study and prepared a clinical study synopsis. We have also identified CROs, that will support us with the execution of our pre-clinical and clinical program.

A health economic survey performed in this study, based on interviews with KOLs and clinicians, allowed us to validate acceptable pricing levels and analyse the willingness-to-pay. We have further strengthened our relationships with clinical, distribution, and pharma partners. TIRmed plans to integrate their expertise into the production process, optimising undertaken activities and expenditures.

The overall results indicate, that there is a substantial need for developing and delivering a safe, efficacious and cost-efficient treatment option for AD. The study allowed us to develop a business plan. enabling reaching our financial and commercialisation targets, aligned with the overall business development strategy of the company.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

TIRmed’s vision is to drive therapeutics development, that will harness innate immune response for the benefit of patients. The current goal is to advance TIR-C, immunomodulatory cream for AD treatment, and validate its efficacy in the clinic. During the feasibility study, we have obtained additional new data on TIRmed´s API acting as a broad-spectrum antiviral. TIRmed´s candidate drug it is currently being evaluated for activity against SARS-CoV2 both in vitro and in vivo in the EC-funded project Fight-nCoV.