A novel, topical drug treatment of diabetic foot infections
| Reference number | |
| Coordinator | CTC CLINICAL TRIAL CONSULTANTS AB |
| Funding from Vinnova | SEK 240 815 |
| Project duration | September 2014 - September 2017 |
| Status | Completed |
| Venture | Eurostars |
Purpose and goal
The overall concept of this project is to conduct a clinical-proof-of-concept trial of a novel antibiotic (LTX-109) in the treatment of infected diabetic foot ulcers. LTX-109, which is being developed by Lytix Biopharma, is a fast-acting, broad-spectrum bactericidal drug acting directly on the bacterial cell membrane by inducing disruption and cell lysis. LTX-109 represents a new and innovative approach by its novel mechanism of action. LTX-109 has demonstrated a very low propensity for resistance development, and has effect upon biofilms and multi-resistant bacterial strains.
Results and expected effects
The main result of the project will be the demonstration of efficacy and safety in a phase IIa study of our novel drug candidate (Proof of Concept) in a new clinical indication warranting further R&D investments.
Approach and implementation
- develop a regulatory strategy - produce Investigational Medicinal Product (IMP) for clinical trials - design, plan, conduct and report the phase IIa study - develop av commersialisation strategy