Ilya Pharma AB says the first patients have been enrolled in a phase II study for its lead candidate ILP100-Topical in patients with diabetic foot ulcers.
Overall, up to 13% of patients with diabetes mellitus of any type develop non-healing ulcers, a physical and psychological disabling condition, where infection of such wound results in a worse five-year mortality rate than most cancers.
The study is fully funded by the European Commission and will be coordinated at Skåne University Hospital.
Trial details of Ilya Pharma’s candidate ILP100-Topical
The trial is a randomized, double-blind, placebo-controlled phase 2a study and aims to evaluate the safety and biologic effects on wound healing of ILP100-Topical. It will include a total of 30 patients with diabetic foot ulcers.
Additional endpoints include reduction in wound infections, antibiotic saving effects, analyses of the mechanism of action and the impact of ILP100-Topical on significant clinical events, during treatment and long term.
The study is designed to allow an assessment of the clinical efficacy on wound healing based on regulatory authorities and expert guidelines in the U.S. and Europe and involves using new technologies such as 3D scanning and blood flow measurements. This will provide data as guidance for the continued clinical development program and designing of the following pivotal trials.
Lactic acid bacteria
Magnus Löndahl, at the Department of Endocrinology, Skåne University Hospital Lund, Sweden, one of the principal investigators, said: “There is a major need for new ways of treating diabetic foot ulcers which unfortunately still often result in amputations. I am intrigued by Ilya’s innovative approach using local sustained delivery of lactic acid bacteria produced chemokines and look forward to the results of the trial and the multiple learnings it should generate.”
Ilya Pharma CEO and co-founder Evelina Vågesjö said: “Dr Löndahl is an acknowledged world expert in prevention of diabetes-related complications. We are delighted to have him and his clinic in Lund in this important trial for ILP100-Topical. We believe we have devised an optimal trial design and included important traits of imaging into the assessments, making datasets more objective and traceable than what has been used before and to more efficiently develop new-in-class pharmaceuticals for this group of patients.”