Wound healing ILYA-style 2

Información del proyecto

WHILYAS-2

Identificador del acuerdo de subvención: 960913

DOI

10.3030/960913

Proyecto cerrado

Fecha de la firma de la CE 26 Noviembre 2020

Fecha de inicio 1 Octubre 2020

Fecha de finalización 31 Diciembre 2023

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 1 943 500,00

Aportación de la UE

€ 1 360 362,00

Coordinado por

ILYA PHARMA AB
Sweden

Periodic Reporting for period 2 - WHILYAS-2 (Wound healing ILYA-style 2)

Período documentado: 2022-01-01 hasta 2023-12-31

Resumen del contexto y de los objetivos generales del proyecto

Unmet medical need targeted in the WHILYAS-2 project:
In Europe 6 million patients with diabets have developed a non-healing ulcer severely limiting the quality of life and resulting in substantial use of antibiotics as well as costs for health care

Why is this important for the society?
-Limiting use of antibiotics limits spread of antibiotic resistance
-Limiting costs for treatment of non-healing and infected wounds free resources in the health care system allowing serving more patients.

Project objectives:
Conduct a randomised controlled clinical phase 2a study in patients with diabetes and a non healing wound.

Overall objectives:
Develop ILP100-Topical as a first -in-class pharmaceutical for the treatment of acute and difficult skin wounds in at risk populations including but not limited to diabetes.
Develop ILP100-Oral as a first -in-class pharmaceutical for the treatment of treatment-induced enterophaties including checkpoint inhibitor induced colitis.
Explore the full potential of drug candidates developed on the ILP-technology platform for different indications in skin and mucosal surfaces where there is a high unmet medical need.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

For the first time the ILP100-Topical is used in real life settings, at hospitals to treat patients. During the WHILYAS-2 project preparations for the clinical trial including Clinical Trial Application and Approval as well as selection and training of the clinical sites have been performed. There has been great learnings in the actual patient population and the patient flows of DFU patients in Sweden during the period and a number of protocol amendments have been implemented to adjust to the actual patient population.

The background data from the phase 1 clinical trial is now published in Öhnstedt et al 2023, eClinical Medicine.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

The ILP100 is more specifically a Limosciliobacillus reuteri expressing the human chemokine CXCL12 1a and have been given the INN name emilimogene sigulactibac by the World Health Organisation and is being developed by the company in a topical and an oral formulation at the moment.

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