Clinical stage gene therapy company, Ilya Pharma, has released further results from the first in human (FIH) trial of ILP100 for treating difficult and chronic wounds.
ILP100 represents a new-in-class drug candidate, engineering Limosilactobacillus reuteri bacteria to produce and release the key human chemokine CXCL12 at the wound site. After delivery, ILP100 enhances the healing properties of immune cells in the wound.
The company reported safety and tolerability endpoints had been met in January, and has now announced that assessment of the multiple quantitative methods used in the trial indicates that ILP100-treated wounds healed on average three days and, for the highest dose, six days faster than controls.
Depending on COVID-19 restrictions, Ilya will now proceed to Phase II in the second quarter of 2021, since this data points to a superior alternative to the other pharmaceuticals currently approved for this indication, of which there are only two.
The FIH clinical trial (EudraCT 2019-000680-24) tested safety and biologic effect of ILP100 administered topically in 36 healthy volunteers, where four or eight wounds were experimentally induced in each subject by a 6mm punch biopsy needle. The one-centre trial was conducted during 2019-2020, and designed as adaptive, randomised, double-blind and placebo-controlled, containing ascending single- and multi-dosing stages.
Treatment with ILP100 in single- and multi-dosing (10 administrations over three weeks) was considered safe and well-tolerated, and systemic exposure or colonisation on the skin were not detected in any of the doses. Blinded assessment of wound healing, defined as fully repithelialised wound area, occurred on site by the principal investigators (PIs) as well as from 2D photographs by three independent evaluators (IEs) with expertise in wound healing and image analysis.
ILP100 significantly accelerated wound healing when compared with control (p<0.05), as 86% (62/72) of the ILP100-treated wounds were healed at or prior to day 32, as assessed by all IEs, compared to 71% of control wounds (51/72 wounds receiving Saline or Placebo), where no differences were detected between the saline- or placebo-treated wounds. With the highest dose 29% more of the wounds treated with ILP100 had healed at day 32 compared to the saline- or placebo-treated wounds in the same cohort.
The time to first registration of the wounds as healed was on average shortened by six days by ILP100 treatment with the largest difference with the highest dose of ILP100 demonstrating 11 days faster wound healing. The healing was assessed at study visits, not continuously.
Furthermore, the volume of the formed scar was at six weeks reduced by 30% for wounds treated with multidose ILP100 when compared to controls (96 wounds per cohort analysed), as measured by 3D spectroscopic scanning.
“We are delighted with these further results which support continued clinical development of ILP100,” said Evelina Vågesjö, CEO of Ilya. “This data, we believe shows that ILP100 is well positioned to be superior to the only two other pharmaceuticals approved. Episalvan was approved in the EU on the basis of 1 day’s accelerated healing, which was considered meaningful to the patients while Regranex and 3c Patch heals approximately 10-15% more of chronic ulcers in patients with diabetes than standard of care.”
Image credit: Diana Polekhina