Scar volume also reduced by 30% through on-site production and delivery of key chemokine CXCL12 by transformed lactic acid bacteria
Uppsala, March 24, 2021: Ilya Pharma, a clinical stage gene therapy company today 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 actual wound site. After delivery, ILP100 enhances the healing properties of immune cells in the wound. After initially reporting safety and tolerability endpoints had been met in January, Ilya has now announced that assessment of the multiple quantitative methods used in the trial indicates that ILP100-treated wounds healed on average 3 days and, for the highest dose, 6 days faster than controls. If the COVID-19 situation allows, Ilya will now proceed to Phase II in Q2, 2021 since this data points to a superior alternative to the only two other pharmaceuticals currently approved for this indication.
Trial design - The FIH clinical trial (EudraCT 2019-000680-24) tested safety and biologic effect of ILP100 administered topically in 36 healthy volunteers, where 4 or 8 wounds were experimentally induced in each subject by a 6mm punch biopsy needle. The one-center trial was conducted during 2019-2020, and designed as adaptive, randomized, double-blind and placebo-controlled, containing ascending single- and multi-dosing stages.
Results - Treatment with ILP100 in single- and multi-dosing (10 administrations over 3 weeks) was considered safe and well tolerated, and systemic exposure or colonization on the skin were not detected in any of the doses. Blinded assessment of wound healing, defined as fully repithelialized wound area, occurred on site by the principal investigators (PIs) as well as from 2D photographs by 3 independent evaluators (IEs) with expertise in wound healing and image analysis. ILP100 significantly accelerated wound healing when compared to 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 6 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 6 weeks reduced by 30 % for wounds treated with multidose ILP100 when compared to controls (96 wounds per cohort analyzed), as measured by 3D spectroscopic scanning.
“We are delighted with these further results which support continued clinical development of ILP100,” says Evelina Vågesjö, Ilya Pharma’s CEO. 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.
Notes to editors.
Ilya Pharma is a clinical stage biopharma, developing novel drug candidates from its propriety technology platform to clinical proof of concept in relevant patient groups with identified unmet medical needs. 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.
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