Oxurion NV reported topline data from a phase 2a study evaluating 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).
The phase 2a randomized, single-masked, active-controlled, multicenter study evaluated the safety and efficacy of 3 monthly intravitreal injections of THR-317 and ranibizumab in subjects with center-involved DME. The combination of ranibizumab and sham was used as a control. A total of 70 patients were enrolled in the study (NCT03499223).
In this exploratory proof of concept study, the efficacy of the combination therapy in terms of the patient’s best corrected visual acuity (BCVA) was assessed as primary endpoint.
At month 3, no improvement was observed in mean BCVA with the combination therapy when compared to ranibizumab monotherapy in the overall population. As measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardized eye chart, the combination therapy achieved an increase of 8.71 letters versus an increase of 8.18 letters for the monotherapy arm.
The combination therapy did show a certain improvement at month 3 in mean BCVA in two pre-specified patient sub-groups:
- In patients with poor (or no) response to prior anti-VEGF, a mean increase of 8.08 letters was observed for the combination therapy vs 6.43 letters increase for ranibizumab monotherapy
- In patients with baseline BCVA ≤65 letters a mean increase of 11.14 letters was observed for the combination therapy vs 8.88 letters increase for ranibizumab monotherapy
Topline data from the phase 2 study show that THR-317 in combination with ranibizumab, is safe and well tolerated. No drug-related ocular serious adverse events were reported in the study.
“The topline results from this exploratory phase 2 study indicate that THR-317 in combination with ranibizumab could play a role in the treatment of poor (or non) responders to prior anti-VEGF and with patients with a baseline BCVA of less or equal to 65 letters,” Patrik De Haes, MD, CEO of Oxurion, said in a company news release. “We will continue to review and analyze these data before deciding on how to best position this program as we progress our clinical-stage portfolio of next-generation therapies for the treatment of DME.”