Oxurion NV announced that all patients have been enrolled in its phase 2 trial evaluating its THR-317, a humanized antibody against placental growth factor (PlGF), in combination with anti-VEGF (ranibizumab), an anti-vascular endothelial growth factor (VEGF) antibody, for the treatment of diabetic macular edema (DME). A total of 70 patients were enrolled in the study, ahead of schedule. Topline data from the study are expected by Q3 2019.
The purpose of the proof of concept study is to evaluate the safety and efficacy of 3 monthly intravitreal injections of THR-317 and ranibizumab in subjects with center-involved DME (CI-DME). The combination of ranibizumab and sham is used as control. Patients will be followed up until 3 months after the last injection (NCT03499223).
Positive data from an earlier phase 1/ 2 study with THR-317 (mono) demonstrated the safety and tolerability of THR-317 for intraocular use. Moreover, reported day 90 data indicated that 30% of anti-VEGF treatment naïve patients (n=40) had a 3 line or more (>15 letters) gain in best corrected visual acuity (BCVA) after 3 monthly injections with THR-317 (8mg). Day 150 showed that 30% of the 8mg anti-VEGF treatment naïve group still showed > 10 letters vision gain.
DME is the result of an accumulation of fluid in the macula – the part of the retina that controls detailed vision – due to leaking blood vessels. DME represents an area of unmet medical need as the current standard of care treatment with anti-VEGF has been shown to deliver suboptimal results in a significant number of patients. It is believed that simultaneously inhibiting VEGF (ranibizumab) and PlGF (THR-317) could deliver incremental benefit over either treatment alone.
“We are delighted to announce the earlier than anticipated full enrollment of our phase 2 study evaluating THR-317 in combination with ranibizumab for the treatment for DME,” Patrik De Haes, MD, CEO of Oxurion nv, said in a company news release. “This proof of concept clinical study will for the first time provide important insights into the additional effect anti-PlGF (THR-317) could provide on top of anti-VEGF therapy, the current standard of care for treating DME patients.”