Oxurion NV announced that further positive topline data from a phase 1 study with THR-687, a novel, potent, pan-RGD integrin antagonist for the treatment of diabetic macular edema (DME), was presented by Arshad Khanani, MD, MA, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, US, at the Angiogenesis, Exudation, and Degeneration 2020 conference on February 8, 2020, in Miami.
“I am delighted to have the opportunity to present these exciting THR-687 data at one of the most reputed global retina meetings. The topline phase 1 data showed that THR-687 was safe and well tolerated at all of the dose levels tested. The study also demonstrated that THR-687 had a rapid positive effect on Best Corrected Visual Acuity (BCVA) that was durable for up to 3 months following just one single injection,” Arshad Khanani, MD, MA, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, and one of the clinical investigators of the THR-687 phase 1 study, said in a company news release. “I believe that these initial findings are very promising and further studies are needed to confirm the efficacy and safety of THR-687 in patients with DME.”
The phase 1, open-label, multi-center (US), single dose escalation study evaluated the safety of a single intravitreal injection of 3 increasing doses of THR-687 (0.4 mg, 1.0 mg, 2.5 mg) for the treatment of DME (NCT 03666923). Patients recruited into the study had a history of response to prior anti-VEGF and/or corticosteroid treatment and remained responsive to treatment according to the investigator assessment.
Topline data from the trial showed that THR-687 was well-tolerated and safe with no dose-limiting toxicities. No serious adverse events were reported at any of the doses evaluated in the study.
The study also looked at efficacy including changes to the patient’s BCVA. Across all doses, a rapid onset of action in mean BCVA was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Month 1. This activity was maintained with a mean BCVA improvement of 8.3 letters at Month 3 following a single injection of THR-687.
A clear dose response was seen with the greatest positive effect on BCVA with the highest dose of THR-687. For this highest dose, a mean BCVA improvement of 11.2 letters was noted at Day 14, with a peak mean improvement of 12.5 letters at Month 3. Further, a peak mean CST (Central Subfield Thickness) decrease of 106 µm was observed at Day 14 with the highest dose of THR-687.
Patrik De Haes, MD, CEO of Oxurion, said: “These encouraging findings from our phase 1 study with THR-687, along with the very positive feedback we have received from the retinal community, highlight the significant potential of this novel integrin antagonist. We are on track to start a phase 2 clinical study with THR-687 in treatment naïve DME patients in H2 2020.”
The presentation made by Dr. Khanani at the Angiogenesis, Exudation, and Degeneration 2020 Conference can be found here.