Belgium - Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a focus on diabetic macular edema (DME), today issues its business and financial update for the period ending September 30, 2020.
Oxurion is focused on developing an industry leading DME franchise based on novel therapies designed to potentially provide improved visual outcomes for DME patients, independent of anti-VEGF. DME is a significant global healthcare problem and the major cause of vision loss in diabetic patients worldwide.
The prevalence of DME was estimated to be 2.8 million people in the US, EU5 and Japan in 2019. The current market value for DME treatments in these markets has been estimated to be approximately $4.5 billion.
The Company is progressing its pipeline of innovative clinical drug candidates for treating DME. Oxurion's clinical development pipeline consists of two novel products with different and complimentary, non-VEGF, modes of action: THR-149 is a potent plasma kallikrein inhibitor with the potential to become the treatment of choice for DME patients who respond sub-optimally to anti-VEGF therapy.
THR-687 is a potential best in class small molecule pan-RGD integrin antagonist being developed to treat DME with the possibility to become the standard of care for all treatment-naive DME patients.
Patrik De Haes, M.D., CEO of Oxurion, commented: 'We have made significant progress in developing our DME franchise in the last eighteen months.
We have recently started our Phase 2 study of THR-149 in patients with DME. This two-part study will first select the optimal dosing regimen of THR-149 and will then compare this in a multiple dosing regimen with aflibercept in terms of the improvements in best corrected visual acuity that it can deliver. This Phase 2 data is designed to support our plans to position THR-149 as the treatment of choice for the large number of DME patients who have a sub-optimal response to anti-VEGF therapy.
In January we announced positive and highly promising Phase 1 results with THR-687 which further strengthened our confidence that this novel pan-RGD integrin antagonist could deliver improved visual outcomes to a broad population of DME patients when compared to anti-VEGFs, the current standard of care. We are currently carrying out additional multiple dose preclinical studies to support an IND (Investigation New Drug Application) as part of our plan to start a Phase 2 study in mid-2021.
I am also pleased to welcome to our senior management team Grace Chang as our new Chief Medical Officer and Tom Graney as Chief Financial Officer. Their experience and expertise will be great assets to the company, and I am confident they will make important contributions to Oxurion's future development. With both Tom and Grace being based in the US, we are starting to build the transatlantic organization we need to deliver on our global ambition.
We believe we are well positioned to build the industry's leading DME franchise, based on successfully developing THR-149 and THR-687, two novel and complimentary drug candidates that could offer improved therapeutic options beyond anti-VGEFs. We are convinced that this focused strategy will deliver significant benefits to DME patients globally as well as value to our shareholders.'
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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 diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.
Oxurion is aiming to build the leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics: THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally 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 evaluating multiple injections of THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy. THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ: BCYC)
THR-687 is a pan-RGD integrin inhibitor, that is initially being developed as a potential new standard of care for all DME patients.
Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021 after receiving regulatory approval.
THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV (Euronext & NASDAQ: GLPG).
Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.
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 US. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable US state securities laws.