Oxurion NV, a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with a clinical stage portfolio in vascular retinal disorders, announces the first patient has been dosed in Part B of its two-part, Phase 2 study (“KALAHARI”) evaluating multiple injections of THR-149 for the treatment of DME.
THR-149 is being developed to potentially become the treatment of choice for the 40-50% of DME patients who respond suboptimally to anti-VEGF therapy. THR-149 acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin) system, a validated VEGF-independent target for DME treatment.
The primary objective of part B of the study is to assess the difference in treatment effect between the selected dose from part A of THR-149 (0.13mg) and aflibercept from Baseline to Month 3, in terms of increase in best-corrected visual acuity (BCVA), the primary endpoint.
Tom Graney, CFA, Chief Executive Officer of Oxurion, comments, “After the success of Part A, we are very happy to begin Part B of the Phase 2 KALAHARI study evaluating THR-149 for the treatment of DME against the current standard of care. Positive results from this Phase 2 trial would confirm THR-149’s potential to provide a much-needed treatment option for DME patients who fail to respond or respond suboptimally to existing anti-VEGF treatment. The success of this study would pave the way to a pivotal trial, that if successful, could position THR-149 to capture an important share of and expand the $4.5 billion DME market, which at the moment is almost entirely served by anti-VEGF therapies.
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. This part of the study will enroll just over one hundred patients, who have previously shown suboptimal response to anti-VEGF. In Part B of the study, which is double-masked and actively controlled, the high dose of THR-149 selected from Part A of the trial will be evaluated against aflibercept as the active comparator.
Final topline results from Part B of the study are expected mid 2023.
Positive Results of Part A of the Study
Clinical results from Part A of the KALAHARI study, which recruited patients who had responded suboptimally to anti-VEGF therapy, demonstrated that all dose levels of THR-149 had a positive safety profile. The side-effects observed in patients were mild to moderate in intensity and there were no cases of severe ocular inflammation.
In terms of efficacy, a rapid onset of action was observed with the highest dose of THR-149 (0.13mg) delivering the greatest improvement in mean best corrected visual acuity (BCVA) of 6.1 letters at Month 3. Within this group, 63% of patients showed at least a 5-letter gain, 38% achieved at least a 10-letter gain, and 13% achieved at least a 15-letter gain at Month 3.
Oxurion intends to present a more complete data set from Part A of the KALAHARI study at an upcoming leading ophthalmology conference.