Ilya Pharma has completed recruitment for a Phase I trial of its lead candidate ILP100-Topical.
Progress has been rapid considering ILP100 is the first drug based on genetically engineered Lactobacillus to be approved to enter trials which has necessitated innovations in CMC, bioassays and protocol development, states the company. Upon successful completion, the company plans to initiate Phase II studies in mid 2021.
ILP100 represents both a novel drug delivery technology and a novel investigational new product (IMP) and is classified as an advanced therapy medicinal product by the EMA and as a low risk candidate under the gene therapy umbrella by the FDA.
ILP is based on deploying chemokines, which until now have been regarded as having too short a half-life in tissue to be effective in major wounds. However, with ILP100, the lactic acid bacteria functions as small bioreactors on site in the wound, continuously introducing the CXCL12 into the wound tissue. The founding team have described and published the full mechanism of action (Vågesjö et al., 2018, PNAS) which involves increasing the levels of CXCL12 in the wound so that “the body thinks that wound is much larger than it really is”. This results in more and more specified immune cells being recruited to the wound, and through e.g. secretion of TGFb, healing being accelerated.
About the trial
The Phase I trial contains two parts, a single ascending dosing in three cohorts and multi ascending dosing in three cohorts. In total 36 healthy volunteers were included. The design and data points are based on the previous scientific findings and rationale and, in addition to the primary objectives of safety and local tolerability there is an extensive part relating to exposure, pharmacodynamics, mechanism of action as well as a larger imaging package including techniques such as non-invasive 3D imaging, monitoring of the microcirculation during the wound healing and scaring and investigations of the wound microbiome. The investment in data is in line with the strategy of Ilya Pharma for the continued clinical development. The study is being conducted in Uppsala, Sweden at the Phase I unit at Uppsala University Hospital.
“Data readout from the multidose part is expected in late Q4 this year, there are many different teams working with the data already now and we look forward to finally be able to share the key findings from both single and multidosing regimes,” says Evelina Vågesjö, Ilya Pharma’s CEO.
Photo of Evelina Vågesjö: Mikael Wallerstedt