ThromboGenics NV reported topline results from a phase 1/2, single-masked, multicenter study to evaluate the safety and efficacy of 2 dose levels (4 mg and 8 mg) of THR-317 for the treatment of diabetic macular edema (NCT03071068).
THR-317 (anti-PlGF) is a recombinant humanized monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF). In preclinical models, anti-PlGF has been shown, in addition to anti-angiogenic and anti-edema properties, to be anti-inflammatory. The THR-001 study enrolled a total of 49 patients, and included anti-VEGF naïve patients as well as sub-optimal anti-VEGF responders.
Initial data reported are for the anti-VEGF treatment naïve group (n=40) up to Day 90; 30 days after the last intravitreal (IVT) anti-PlGF administration. The primary focus of this study was safety outcomes. THR-317 was safe and well tolerated. No dose-limiting toxicities or relevant safety events were reported at either dose level.
Thirty percent of the anti-VEGF treatment naïve study subjects treated with THR-317 in the 8mg group showed a > or equal to 15 letter gain from baseline at Day 90 versus 5.3 % in the 4mg group.
These data support initiation of a next study evaluating THR-317 in combination with an anti- VEGF. Clinical trial is targeted to be initiated in Q2 2018.
Final results from the THR-317-001 study are being planned for presentation at an upcoming ophthalmology meeting.
“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. It is an exciting time for us at ThromboGenics as we continue to evaluate new therapeutics for diabetic eye disease. We believe that this remains an important area of unmet medical need," Susan Schneider, MD, Chief Medical Officer of ThromboGenics, said in news release.