Oxurion Announces the Continuation of KALAHARI Phase 2, Part B Study in DME Following Interim Analysis
Oxurion NV announced that an Independent Data Monitoring Committee (IDMC) completed its planned interim analysis of the KALAHARI phase 2, Part B clinical trial evaluating Oxurion’s novel plasma kallikrein (PKal) candidate, THR-149, as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of diabetic macular edema (DME).
The IDMC recommended continuation of the study based upon the outcome of the futility analysis. The IDMC assessment included an evaluation of interim efficacy and safety data from 3-month data, with a total of 31 patients. Topline data from the study is anticipated in the second half of 2023.
“We are very pleased to continue the KALAHARI trial following the IDMC’s recommendation after their review of our interim data,” Andy De Deene, MD, Chief Development Officer of Oxurion, said in a company news release. “This trial is evaluating THR-149 for the treatment of DME against the current standard of care anti-VEGF therapy. THR-149 could provide an important alternative for the up to 50% of patients with DME who respond suboptimally to anti-VEGF.”
Oxurion’s Chief Executive Officer, Tom Graney, CFA, added, “Continuing this trial based on the results of the interim analysis is a critical milestone for patients with DME, which is the leading cause of blindness in working-age people. We look forward to completing this study, which, if positive, would enable phase 3 development that could position THR-149 as an important second line therapy in the $5+ billion global DME market.”
About THR-149
THR-149 is a bicyclic peptide that selectively inhibits human plasma kallikrein (PKal) with an inhibition constant of 0.22 nM. Through the inhibition of the kallikrein-kinin system (KKS), THR-149 prevents the induction of retinal vascular permeability, neurodegeneration, and inflammation.
THR-149 is currently being evaluated in the KALAHARI Phase 2, Part B clinical trial as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of DME.
KALAHARI Phase 2, Part B
Part B is the second part of the phase 2 KALAHARI study, a two-part, randomized, prospective, multi-center study assessing multiple (3) injections of THR-149 in DME patients. Part B is double-masked and actively controlled, with the high dose of THR-149 selected from Part A of the trial being evaluated. Part B of the study is enrolling just over one hundred patients who have previously shown a suboptimal response to anti-VEGF therapy, and where THR-149 is being evaluated against aflibercept, the current standard of care, as the active comparator.