THR-317 for the treatment of diabetic macular edema was found to be safe and well tolerated in a phase 1/2 study, ThromboGenics announced.
The single-masked, multicenter THR-001 study evaluated THR-317, a recombinant humanized monoclonal antibody directed against the receptor-binding site of human placental growth factor, for safety and efficacy at two dose levels, 4 mg and 8 mg, according to a press release.
Forty-nine anti-VEGF-naive subjects and suboptimal anti-VEGF responders were enrolled. These results pertain to the 40 patients who were treatment-naive.
No dose-limiting toxicities or safety issues were seen at either level, the release said.
Thirty percent of treatment-naive patients treated with 8 mg saw a 15 or greater letter gain at day 90, while 5.3% treated with 4 mg had a 15 or greater letter gain.
“This is a key step in our development of this novel compound for the treatment of patients with DME. We are very encouraged by these initial data that show safety and tolerability of THR-317 as well as clinical activity in this population,” Susan Schneider, MD, ThromboGenics chief medical officer, said in the release.