Phase 1/2 Study Evaluating THR-317 for DME Meets Primary Safety Endpoint

Source: Oxurion NV

Oxurion NV announced that clinical-stage data from a phase 1/2 study evaluating its anti-placental growth factor candidate THR-317 for the treatment of diabetic macular edema (DME) were presented at the FLORetina 2019 meeting in Florence, Italy. THR-317 (anti-PlGF) is a recombinant humanized monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF).

Anat Loewenstein, MD, MHA, professor of ophthalmology and chair of the ophthalmology division at the Tel Aviv Medical Center, delivered a presentation highlighting results from the phase 1/2 trial evaluating the safety and efficacy of intraocular THR-317 at two dose levels (4 mg and 8 mg) for the treatment of DME. The study met its primary endpoint of safety for both the 4-mg and 8-mg doses. Efficacy was also observed in the study. Overall, patients receiving the 8-mg dose of THR-317 achieved better visual acuity outcomes than in the 4-mg dose group.

Dr. Loewenstein said, “I feel encouraged by these phase 1/2 data that show safety and efficacy of the 8-mg dose of THR-317 in patients with DME. I look forward to seeing the outcome of the proof-of-concept phase 2 trial that is due in the coming months. These data will provide important insights into the additional effect anti-PlGF could provide on top of anti-VEGF therapy, the current standard of care for treating DME patients.”

A phase 2 study of 8-mg THR-317 in combination with anti-VEGF (ranibizumab, Lucentis) is ongoing. The study is evaluating THR-317 in combination with conventional anti-VEGF therapy (Lucentis) versus anti-VEGF therapy (and sham) for the treatment of DME. In April 2019, Oxurion announced full enrollment of this phase 2 study (n=70) ahead of schedule.

Topline data from this phase 2 study are expected in Q3 2019.

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