Ilya Pharma Receives Approval from Swedish Regulators for Phase II Study

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

Clinical-stage gene therapy company, Ilya Pharma, has announced, in a June 23, 2021 press release, that it has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

ILP100 has been developed for the treatment of difficult diabetic wounds by enhancing the healing properties of immune cells at the wound site. This regulatory approval for the next stage of clinical trials comes after Phase I results indicated that the gene therapy, in its highest dose, was able to treat wounds in healthy subjects with a healing time of approximately six days on average, which is 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 in one of the intended patient groups for future commercial use of ILP100 where today’s standard of care is not sufficient,” said Andreas Fasth, Ilya Pharma’s head of Clinical Developments, in the press release. “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 [artificial intelligence]-augmented imaging technology as well as non-invasive imaging of blood perfusion, and at the same time further characterize ILP100 in a clinical setting.”

“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,” added Evelina Vågesjö, Ilya Pharma’s CEO, in the press release. “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 [proof of concept] 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 [gastrointestinal] tract.”

Source: Ilya Pharma