OXUR Oxurion NV

THR-149 and THR-687 show targeted activity in the eye following intravitreal injection with low systemic exposure

Novel pharmacokinetic models developed by Oxurion may have broad utility to analyze systemic exposure of a wide variety of drugs delivered in the eye

Leuven, BE, Boston, MA, US – August 16, 2021 – 8.00 AM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care therapies for retinal vascular disorders, announces the publication of two related papers in the Journal of Pharmacokinetics and Pharmacodynamics entitled “Systemic exposure following intravitreal administration of therapeutic agents: an integrated pharmacokinetic approach.”

These papers describe the pharmacokinetic properties of THR-149 and THR-687 following intravitreal (IVT) injection in animals and utilize novel pharmacokinetic models developed by Oxurion to accurately assess the systemic levels of these exciting novel drug candidates, which are both in clinical development for diabetic macular edema (DME).THR-149 is a 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. With that, THR-149 holds potential to grow the existing $4.5B DME market.

THR-687 is a pan-RGD integrin antagonist initially being developed as a potential first line therapy for treatment of DME patients. In addition, Oxurion believes that THR-687 could deliver improved clinical outcomes to the large number of patients with wet age macular degeneration (AMD) and retinal vein occlusion (RVO) which together with DME represents a >$12B market opportunity.

IVT injection remains the preferred route of administration for pharmacological agents intended for the treatment of back of the eye diseases such as diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD).  The procedure enables drugs to be delivered locally at high concentrations whilst limiting systemic exposure and associated risk of systemic adverse events.

Intravitreally-delivered drugs do, however, enter the general circulation and achieving an accurate understanding of systemic exposure as enabled by these new pharmacokinetic models is pivotal for the evaluation and development of drugs administered in the eye.

Prof Alan Stitt, Ph.D., Chief Scientific Officer (CSO) of Oxurion, said, “These publications in the Journal of Pharmacokinetics and Pharmacodynamics underline the highly attractive clinical profiles of both THR-149 and THR-687. Both compounds show a short intravitreal half-life but sustained biological activity with low systemic exposure due to their rapid clearance. This enables targeted activity in the eye combined with minimal risk of systemic side effects. The animal models and analytical techniques that we have developed have proven accurate in predicting circulating plasma levels of these novel drug candidates following intravitreal injection, and potentially have broad predictive value for a variety of therapeutics administered by IVT. These publications reflect the calibre and thought leadership of the high-quality science that we are generating at Oxurion.”

Articles can be accessed at:

https://link.springer.com/article/10.1007/s10928-021-09773-w

https://link.springer.com/article/10.1007/s10928-021-09774-9

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About Oxurion

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 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 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 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 evaluating multiple injections of THR-149 in DME patients previously showing suboptimal response to anti-VEGF therapy. Dose selection data from Part A of the study, which is fully enrolled, is expected in the second half of 2021.

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.

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