SITU-SAFE is an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trial (EudraCT 2019-000680-24) consisting of a single (SAD) and a multiple ascending dose (MAD) part of three dose cohorts each. In all individuals and doses, ILP100-Topical was safe and well-tolerated with no systemic exposure. A combined cohort analysis showed a significantly larger proportion of healed wounds (p = 0.020) on Day 32 by multi-dosing of ILP100-Topical when compared to saline/placebo (76% (73/96) and 59% (57/96) healed wounds, respectively). In addition, time to first registered healing was shortened by 6 days on average, and by 10 days at highest dose. ILP100-Topical increased the density of CXCL12+ cells in the wounds and local wound blood perfusion. The favourable safety profile and observed effects on wound healing support continued clinical development of ILP100-Topical for the treatment of complicated wounds in patients
Addressing target audiences and expressing needs
- To raise awareness and possibly influence policy
- Other blended financing
- Collaboration
The ILP100-Topical is being evaluated in phase 2 clinical trials in nonhealing wounds in diabetic patients (phase 2a) and surgical wounds in prediabetic, diabetic and obese patients (IND cleared for pivotal trial) and we are nor reaching out to investors and industrial parties to acclerate the development, also in specific reagions and other indications.
- Public or private funding institutions
- EU and Member State Policy-makers
- Research and Technology Organisations
R&D, Technology and Innovation aspects
Evaluation in two clinical trials in patients
pipeline in a product
geographical licencing possible
indication specific licencing possible
multiple stages of development have been published in patents and scientific journals
Pharmaceutical proucts need to become more cost efficient, the ILP-technology and on site production facilitates this
- Middle-East
- Asia
- Europe
- North America
- Global
