Wound healing ILYA-style 2

Project Information

WHILYAS-2

Grant agreement ID: 960913

DOI

10.3030/960913

Project closed

EC signature date 26 November 2020

Start date 1 October 2020

End date 31 December 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 943 500,00

EU contribution

€ 1 360 362,00

Coordinated by

ILYA PHARMA AB
Sweden

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

Reporting period: 2022-01-01 to 2023-12-31

Summary of the context and overall objectives of the project

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.

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

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.

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)

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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