Back to search

PES2020-Prosj.etabl.støtte H2020

LTX-109 for the treatment of diabetic foot infections.

Awarded: NOK 0.15 mill.

The main deliverable will be to provide solid evidence that there is a potential clinical efficacy of LTX-109 in treating infected diabetic foot ulcers. This will be done through a rigorous, well-designed, randomised controlled clinical trial which will thus comprise the main Work Package. Following this proof-of-concept study, another phase 2 study related to dose-finding would be planned and conducted. In parallel there would be negotiations and consultations with European and US regulatory agencies in order to agree a clinical roadmap for the pivotal phase 3 studies and also any required supportive studies would be identified and planned. The main challenges relate to the general complexity of conducting clinical trials of novel drug candidates as it involves a multidisciplinary team of scientists and support functions. Drug development is extremely costly and time-consuming, and includes a significant risk element (in terms of lack of efficacy or toxicities), as a general inborn issue. Also drug d evelopment competency as well as resource availability (human as well as financial) is required. Even if Lytix has a core team of clinical research scientists, extra competency and capacity is being sought through strategic selection of project partners. This is why one of the key collaborators is a CRO (SMERUD) with proven expertise in clinical trial management, but as important, also with financial viability and strength to participate as a project beneficiary (partner) without requiring a sub-contracti ng status. The potential use of the project results is for further clinical development of LTX-109. Delivering a succesful result means that clinical proof-of-concept has been demonstrated,which would encourage further studies to characterise the optimal dosing of LTX-109 in the diabetic foot infection setting. A succesful result of the project would also facilitate attraction of major big pharma partners to take the drug through rigorous global phase 3 trials.

Funding scheme:

PES2020-Prosj.etabl.støtte H2020