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Oxurion NV - Data from Phase 1/2 Clinical Study evaluating THR-317 (anti-PlGF) for DME presented at 2019 FLORetina Meeting
Leuven, Belgium, 6th June 2019 – 7 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease,announced that today 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 biannual Retina Meeting (FLORetina 2019) 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).
Professor Anat Loewenstein, MD MHA, Professor of Ophthalmology, Chair of the Ophthalmology Division at the Tel Aviv Medical Center, delivered a presentation entitled “A Phase 1/2 safety and efficacy study of Anti-PlGF (THR-317) in diabetic macular edema”. The Phase 1/2 study enrolled 49 patients and comprised anti-VEGF naïve patients as well as sub-optimal anti-VEGF responders.
The presentation highlighted results from a Phase 1/2 trial evaluating the safety and efficacy of intra-ocular THR-317 at 2 dose levels (4 mg and 8 mg) for the treatment of DME. The study met its primary endpoint of safety for both the 4mg and 8mg doses. Efficacy was also observed in the study. Overall, patients receiving the 8mg dose of THR-317 achieved better visual acuity outcomes than in the 4mg dose group.
In April 2018, Day 90 (30 days after last injection) topline data announced from this Phase 1/2 study demonstrated that intra-ocular THR-317 was safe and well tolerated. The data also showed that 30% of anti-VEGF treatment naïve patients achieved a 15 letter vision gain in BCVA (Best Corrected Visual Acuity).
In July 2018, Day 150 (90 days after last injection) topline data from this study showed that in the 8mg anti-VEGF treatment naïve group, 30% of these patients achieved a ≥ 10 letter vision gain and 10% showed a ≥15 letter vision gain. The Day 150 data demonstrate the durability of THR-317’s positive effect on vision in this patient population.
Professor Anat Loewenstein, commented: "I feel encouraged by these Phase 1/2 data that show safety and efficacy of the 8mg 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 8mg THR-317 in combination with anti-VEGF (ranibizumab, Lucentis®) is on-going. 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.