Phase 1 study results for THR-149, Oxurion’s plasma kallikrein inhibitor, showed it to be safe and well tolerated with a rapid onset of action from the first day of treatment in patients with diabetic macular edema, according to a press release.
The open-label, multicenter, non-randomized trial evaluated a single intravitreal injection of THR-149 at three ascending dose levels in 12 patients. After 14 days, the average best corrected visual acuity improved up to 7.5 letters, with an average BCVA improvement of 6.5 letters at day 90, the release said.
“These positive findings provide us with the information and confidence needed to plan the next stage of THR-149’s clinical development. 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,” Patrik De Haes, MD, CEO of Oxurion, said in the release. “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.”