Ilya Pharma developing has announced that a first-in-human trial for its lead candidate, ILP100, has been approved by the Swedish Medical Products Agency.
ILP100 is based on genetically engineered lactic acid bacteria that express the human chemokine CXCL12, known to be involved in tissue regeneration.
Administered topically at the actual wound site, 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.
Chemokines are known to have a short half-life in tissue. 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, 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 the secretion of TGFb, for example, healing being accelerated.
The first-in-human/Phase I trial comprises two parts: a single ascending dose part and a multi-ascending dose part with, in total, 36 healthy volunteers to be included.
The study will be conducted in Uppsala, Sweden, at the Phase I unit at Uppsala University Hospital. The design and data points are based on the previous scientific findings and rationale and, in addition to the safety assessments, the study includes techniques such as non-invasive 3D imaging, monitoring of the microcirculation during the wound healing and investigations of the effect on the full wound microbiome.
The study has an extensive analytical component and this has been in part been developed together with experts and the relevant regulatory bodies including the Swedish MPA.
"We are delighted that the MPA has approved our trial design as there is nothing “standard” about either our project, the IMP, or this first trial,” says Evelina Vågesjö, Ilya Pharma’s CEO.
“This is one of the first clinical trials to be conducted with genetically engineered bacteria as a biologic and the first to be started with a topical IMP of this kind. However, the MPA are very positive towards innovation and good science and in particular towards our professional team in the new wave of next-generation biologics that is emerging."
According to Vågesjö, ILP100 as a future product is developed to have low barriers for clinical implementation: “We have deliberately invested in an extensive study with long treatment periods to be able to cover more difficult wound indications in the future clinical programme. In addition, compared with the majority of other next-generation biologics — such as cell or gene therapy IMPs — ILP100 is a scalable product with excellent stability and very low manufacturing costs.”
Patient enrolment will commence after the summer and the active phase of trial is expected to be completed in late Q1 2020.