Developing next generation treatments to preserve vision for patients with diseases affecting the back of the eye

Positive Phase 2 Part A THR-149 data shared at the America Society of Retina Specialists (ASRS) Annual Scientific Meeting

11 Oct 2021
  • Patients in the highest dose group achieved an overall mean 6.1 letter improvement in Best Corrected Vision (BCVA) at Month 3, of which:
    • 63% showed at least a 5-letter gain
    • 38% achieved at least a 10-letter gain
    • 13% achieved at least a 15-letter gain
  • Oxurion intends to present a more complete data set from Part A of the KALAHARI study at an upcoming leading ophthalmology conference

Leuven, BE, Boston, MA, US – October 11, 2021 – 07.00 AM CETOxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, is delighted to announce that further characterization of the BCVA data from the previously reported Part A portion of the Phase 2 ("KALAHARI") study of THR-149 was shared at the American Society for Retina Specialists (ASRS) Annual Scientific Meeting.

THR-149 is a plasma kallikrein inhibitor, being developed for the treatment of the 40-50% of DME patients who sub-optimally respond to standard of care anti-VEGF therapy.

As previously announced, results from Part A demonstrated that all dose levels of THR-149 had a favorable safety profile. All adverse events in the study eye were mild to moderate in intensity and no severe ocular adverse events were reported and no inflammation observed.

The highest dose of THR-149 (0.13mg) produced the largest improvement in BCVA, the primary endpoint for registration in DME studies. The highest dose delivered a mean 6.1 letter improvement at Month 3 with no patients requiring rescue medications.

Further characterization of the BCVA data was shared yesterday during ASRS by Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, US, “I am happy to report that in patients, who had been suboptimally treated with anti-VEGF therapy, the highest dose of THR-149 was able to achieve at least a 5-letter gain in 63% of patients, of these 38% patients achieved at least a 10-letter gain, and 13% saw at least a 15-letter gain. In addition, CST was stable and a change of 13 µm observed at Month 3. These results demonstrate the potential of THR-149 to make a real difference to this patient population, which if left untreated would be expected to see a further deterioration in their vision.”

Tom Graney, CFA, Chief Executive Officer of Oxurion, comments, “These data provide proof of concept for multiple injections of THR-149, our potent plasma kallikrein inhibitor, in this important underserved DME patient population. We are very excited that in these patients, who currently do not have suitable treatment options, over 60% gained at least a full line improvement in vision from baseline when treated with the highest dose of THR-149.”

In Part B of this study, we hope to confirm THR-149’s ability to address the significant unmet need in this large patient population that experience a suboptimal response to anti-VEGFs and as a result currently lack adequate treatment options.”

Based on the results from Part A of the Phase 2 study, the Company is advancing the high dose of THR-149 (0.13mg) into Part B of the study which will enroll just over one hundred patients who have previously shown a suboptimal response to anti-VEGF therapy, and where THR-149 will be evaluated against aflibercept, the current standard of care, as the active comparator. Final topline results from the KALAHARI study are expected in mid-2023.

Oxurion intends to present a more complete data set from Part A of the KALAHARI study at an upcoming leading ophthalmology conference.

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Tags: 
Clinical update; THR-149