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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 CET – Oxurion 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 Retinal 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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Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with retinal vascular disorders including diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).
Oxurion is aiming to build a leading global franchise in the treatment of retinal vascular disorders based on the successful development of its two novel therapeutics:
THR-687 is a highly selective pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. Oxurion is currently conducting a Phase 2 clinical trial (“INTEGRAL”) evaluating THR-687 in patients with DME. THR-687 also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.
THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The company is currently conducting a Phase 2 clinical trial (“KALAHARI”) evaluating multiple injections of THR-149 in DME patients previously showing a suboptimal response to anti-VEGF therapy. Following positive data from Part A of this Phase 2 study (dose selection), the Company has initiated Part B of the study.
Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. More information is available at www.oxurion.com.
Important information about forward-looking statements
Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.