Initial data shows the safety and tolerability of ThromboGenics NV's (EBR: THR) THR-317 therapy for the treatment of diabetic macular edema, the biotechnology company announced on Wednesday.

The Phase 1/2, single-masked, multi-centre study evaluated the safety and efficacy of two dose levels (4mg and 8mg) and enrolled 40 anti-VEGF treatment naïve patients and nine anti-VEGF sub-optimal responders.

THR-317 (anti-PIGF) is a recombinant humanised monoclonal antibody that is directed against the receptor-binding state of human placental growth factor (PIGF). Pre-clinical models demonstrated anti-PIGF has anti-angiogenic, anti-edema and anti-inflammatory properties.

Initial data for the anti-VEGF treatment naïve group revealed that THR-317 was safe and well tolerated. There were no dose-limiting toxicities or relevant safety events reported at either dose level.

This was the first clinical trial to evaluate the safety and efficacy of an anti-PIGF antibody for intravitreal use. Final results from the THR-317-001 study will be presented at an upcoming ophthalmology meeting.