Ilya’s Pharma Receives Approval from Swedish Regulators to Initiate Phase II Clinical Study of ILP100 Gene Therapy to Treat Difficult Wound Patients with Diabetes
Follows highly promising Phase I results from on-site production and delivery of key chemokine CXCL12 by transformed lactic acid bacteria for accelerated wound healing.
Uppsala, June 23, 2021: Ilya Pharma, a clinical stage gene therapy company today announced that it has received approval from the Swedish Medical Product Agency and Swedish Ethical Review Authority to initiate a Phase II clinical study of its ILP100 gene therapy for the treatment of difficult diabetic wounds (EudraCT 2021-000563-69). ILP100h has recently been assigned the INN name emilimogene sigulactibac by the WHO and 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. Phase I results released earlier this year indicate that ILP100-treated wounds in healthy subjects healed on average 6 days and, for the highest dose, 11 days faster than controls.
“With the phase II clinical trial, we will for the first time study the biologic effect of ILP100 in difficult wounds in patients one of the intended patient groups for future commercial use of ILP100 where today’s standard of care is not sufficient. We have designed this 26-week trial to both allow assessment of the clinical outcomes mentioned as the most important by patients and regulatory authorities, including detailed wound analyses with AI-augmented imaging technology as well as non-invasive imaging of blood perfusion, and at the same time further characterize ILP100 in a clinical setting,” says Andreas Fasth, Ilya Pharma’s Head of Clinical Developments.
“This is a true milestone in both the clinical development of ILP100 and proof of the concept of using local delivery of biologics by the ILP-technology platform as we move to Phase II, “says Evelina Vågesjö, Ilya Pharma’s CEO. “We now look forward to showing biological effects on wound healing and important long term clinical outcomes in patients with diabetes and difficult non-healing wounds. Here ILP100 has the potential to prove superior to the only other two pharmaceuticals approved as we already have much better positioning and PoC data. In addition, we will proceed with the planned clinical development in treatment of postsurgical wounds in obesity, diabetes and prediabetes, as well as pre-clinical- development and clinical positioning for ulcers of the GI tract.”
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.
Evelina Vågesjö, CEO
Tel: +46 (0) 70 636 64 94
Richard Hayhurst, RHA
Tel: +44 (0) 7711 281527