Ilya Pharma AB (the Company), a clinical stage immunotherapy company today announced that FDA have cleared an IND for its lead candidate ILP100-Topical and that the Company is immediately accelerating preparations for large adaptive Phase 2 study, designed as a pivotal trial. ILP100-Topical is a first-in-class immunotherapy designed to treat surgical wounds in patients with prediabetes, diabetes and obesity. These patients have weeks to months delayed healing following surgery and a substantially increased risk of serious wound complications.
Robert D. Galiano, MD, FACS Associate Professor; Director of Research; Division of Plastic Surgery Northwestern University Feinberg School of Medicine, will be the National Coordinating Investigator and Study Chair for the study which will include 260 patients. Following the ongoing work by the Wound Experts/FDA Clinical Endpoints Project (WEF-CEP) and trends in other areas such as oncology and rheumatoid arthritis, the selected primary endpoint is a composite endpoint of complication free healing. The study has an adaptive design and comprises two parts – the first being a dose finding part and the second a confirmatory part. Thanks to the internal control design, where each patient is its own control with one wound treated with placebo and one wound treated with ILP100-Topical, the study is significantly de-risked, the number of enrolled patients reduced and the bias between the treatment groups minimized.
Dr Galiano commented: “One does not have to have diabetes to be afflicted with impediments in wound healing, and not only is this underappreciated, but we also do not have any therapeutics that target this impairment in healing. The effect of obesity is a silent epidemic and affects every surgical discipline. A therapeutic that improves surgical wound healing would result in improved outcomes in all surgical specialties and procedures, not just in breast reductions. I am therefore delighted to lead this trial having seen the impressive results already obtained by Ilya in their Phase I study.”
Ilya Pharma CEO and Co-Founder Evelina Vågesjö adds: “The clearance came quicker than expected, we are now aiming to treat the first patient in Q3 this year. This is also a pivotal moment for Ilya Pharma after amazing efforts by our great team. Working closely with Dr Galiano and a group of experts and KOLs we believe we have devised an optimal trial design that will demonstrate the truly transformational benefits of ILP100-Topical to patients, starting with this at-risk population. In addition,this milestone validates our ILP-technology platform and other drug candidates in development which we have noticed are gaining increasing interest.”