Oxurion reported additional positive topline data from a phase 1 study with THR-149, a novel, potent, plasma kallikrein (PKal) inhibitor for the treatment of diabetic macular edema (DME).
This phase 1 open-label, multicenter (US), non-randomized trial evaluated the safety of a single intravitreal (IVT) injection of THR-149, a novel PKal inhibitor, at 3 ascending dose levels in 12 subjects with visual impairment due to center-involved DME (CI-DME) (NCT03511898). THR-149 has been developed in partnership with Bicycle Therapeutics. Oxurion holds the exclusive license to the PKal inhibitor portfolio originating from this partnership.
Topline data from the trial show that THR-149 is well-tolerated and safe. No dose-limiting toxicities nor drug-related serious adverse events were reported at any of the dosages evaluated in the study.
The study looked at efficacy including changes to the patient’s Best Corrected Visual Acuity (BCVA), Mean CST (Central Subfield Thickness) and MV (Macular Volume).
A rapid onset of action was observed from Day 1, with an increasing average improvement in BCVA of up to 7.5 letters at Day 14. This activity was maintained with an average improvement in BCVA of 6.5 letters at Day 90 following a single injection of THR-149. In addition, mean BCVA gain was fast and maintained until end of study.
CST change was within the variability of measurement. Macular Volume correlates with BCVA improvement.
“The immediate onset of action and the duration of the BCVA improvement following 1 injection of THR 149 are impressive,” Pravin Dugel, MD, Managing Partner of Retinal Consultants of Arizona and Clinical Professor of Roski Eye Institute, Keck USC School of Medicine, said in a company news release. “Mean CST findings are within variability of measurement. Macular Volume correlates with reported BCVA improvement, potentially offering a new anatomical predictor for BCVA improvement. Overall, the data from this study clearly warrant further clinical research with multiple injections of THR-149.”
“These positive findings provide us with the information and confidence needed to plan the next stage of THR-149’s clinical development,” Patrik De Haes, MD, CEO of Oxurion, said in the news release. “They also demonstrate that THR-149 has the clinical profile to potentially become the best-in-class PKal inhibitor and VEGF independent therapy for the treatment of DME. We are currently preparing to initiate a Phase 2 study with multiple injections of THR-149 and anticipate the enrollment of the first patient in early 2020.”
Full data from this phase 1 study will be presented and discussed by Dr. Dugel during Retina Society Meeting on Sunday September 15, 2019 in London.