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EUROSTARS-EUROSTARS

E!9146 LTX-109 for the treatment of diabetic foot infections

Alternative title: LTX-109 for behandling av infiserte diabetes fotsår

Awarded: NOK 2.8 mill.

Project Manager:

Project Number:

244901

Project Period:

2014 - 2017

Funding received from:

Location:

Partner countries:

Infected foot ulcers is an emerging problem for patients with diabetes. Such foot ulcers may develop severe infections, which may lead to amputations. Today, no topical drug to treat mild infected diabetic foot ulcers is approved, and there is a large medical need to develop treatments for this indication. The overall objective for the CureDFI-project is to conduct a clinical Phase 1/2 study with the antimicrobial peptide LTX-109 in the treatment of patients with mild infected diabetic foot ulcers. LTX-109, is a fast-acting bactericidal drug, developed by Lytix Biopharma. LTX-109 works by directly affecting the bacterial cell membrane. LTX-109 is formulated in a hydro gel and is administered by direct application on the wound. The primary objective is to assess the clinical response of treatment with LTX-109 in patients with mild infected diabetic foot ulcers. In this project, there will be consultations with European and US medicinal regulatory agencies in order to agree to the clinical development plan for further development of LTX-109 within diabetic foot ulcers. This project is a collaboration between four partners in Europe to jointly deliver study results through the planned clinical Phase 1/2 study and to plan the road-map up to commercialisation.

The main deliverable of the CureDFI project is to provide evidence that there is a potential clinical efficacy of LTX-109 in treating mild infected diabetic foot ulcers. This will be done through the data generated in a clinical Phase 2 trial which will comprise the main Work Package. This clinical trial will aim to find the effective and safe dose of LTX-109 to treat mildly infected diabetic foot ulcers in addition to prove the efficacy of LTX-109 as treatment in mild infected diabetic foot ulcers over placebo. There will also be negotiations and consultations with European and US regulatory agencies in order to agree a clinical road-map for the pivotal Phase 3 studies. This project is a collaboration between four SME partners to jointly delivering a successful result through a proof-of-concept clinical Phase 2 study. A successful result of the project would also facilitate attraction of potential pharma partners to take the drug through rigorous global Phase 3 trials.

Funding scheme:

EUROSTARS-EUROSTARS