Oxurion NV announced that it has completed enrollment of its phase 1 study of THR-149, a novel plasma kallikrein (PKal) inhibitor for the treatment of diabetic macular edema (DME). A total of 15 patients have been recruited. The study enrolled faster than anticipated and initial data will be released by early Q3 2019.
The phase 1 trial is designed to evaluate the safety of a single intravitreal (IVT) injection of THR-149 a novel PKal inhibitor, of 3 ascending dose levels in subjects with visual impairment due to center-involved DME (CI-DME) (NCT03511898).
Activation of the PKal enzyme has been shown to induce retinal vascular permeability, microaneurysm, and inflammation. Based on literature data, patients with DME have elevated levels of plasma kallikrein.
Encouraging preclinical studies involving THR-149 were published in The Journal of Medicinal Chemistry in March 2018. These data demonstrate the potency and efficacy of bicyclic peptide inhibitors of PKal, such as THR-149, via a VEGF-independent pathway.
“We are delighted to have completed patient recruitment in this important clinical trial earlier than anticipated,” Patrik De Haes, MD, CEO of Oxurion, said in a company news release. “This study has been designed to assess THR-149’s safety profile and to provide the information needed to plan the future clinical development plan of this novel plasma kallikrein inhibitor for the treatment of DME.”