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

Oxurion NV Business and Financial Update – FY 2020

17 Mar 2021

Advancing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies – with Novel MoAs Beyond anti-VEGF

Recruiting Phase 2 study (‘KALAHARI’) evaluating THR-149, a potent plasma kallikrein inhibitor in DME – On track for Part A data by mid-year 

Positive data Phase 1 study evaluating THR-687, potential best in class pan-RGD integrin antagonist in DME – On track to start Phase 2 by mid-year

Highlights       

  • Industry-leading pipeline targeting a total potential market opportunity of $12 billion in retinal vascular disorders
  • First patients dosed in Phase 2 study (‘KALAHARI’) evaluating multiple injections of THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME. Part A data expected by mid-year
  • THR-687, a pan-RGD integrin antagonist, Phase 2 DME study planned to start by mid-year, following positive Phase 1 data released in 2020
  • The Company has strengthened the management team with the appointments of Tom Graney, CFA, based in Boston as CFO, Grace Chang M.D., PhD, based in LA as CMO, and Professor Alan Stitt, PhD as CSO.                   
  • At the end of December 2020, Oxurion had cash, cash equivalents & investments of €24.8 million, allowing the Company to execute on its business plans through the end of Q3 2021.  The Company is in advanced discussions with potential investors in order to increase its cash position. 

Leuven, Belgium, Boston, MA, US – March 17, 2021 – 19.30 PM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with an initial focus on diabetic macular edema (DME), today issues its business and financial update for the twelve-month period ending December 31, 2020.

Oxurion is focused on developing an industry leading DME franchise based on novel therapies. These new drug candidates, which have novel modes of action, largely independent of anti-VEGF pathways, have been designed to improve visual outcomes for all DME patients and to deliver other important clinical benefits.

DME is a significant and growing global healthcare problem and the major cause of vision loss in persons with diabetes worldwide. Global prevalence of DME is estimated to be 28 million people in 2019.[1] The current market value for DME treatments globally is estimated to be approximately $4.5 billion.

The Company is advancing its pipeline of innovative clinical drug candidates for treating DME. Oxurion’s clinical development pipeline consists of two novel product candidates with different and complementary modes of action:   

  • THR-149 is a potential first in class plasma kallikrein inhibitor with the possibility 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 most DME patients.

By advancing both of these exciting new drug candidates, with differentiated modes of action, Oxurion expects to bring much needed innovation and improved clinical outcomes to patients with DME.

Beyond DME, THR-687 also has development possibilities in additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12 billion.

Patrik De Haes, M.D., CEO of Oxurion, commented:

“The last 12 months have seen further important progress towards Oxurion’s goal of building the industry leading DME franchise based on bringing much needed innovation to this significant market opportunity. Over this period, we have advanced the clinical development of our lead assets and been successful in making a number of significant senior management appointments.

In September 2020, we dosed the first patients in the Phase 2 KALAHARI study of our potential first in class plasma kallikrein inhibitor THR-149. These patients with DME have sub-optimally responded to previous anti-VEGF. This two-part study is an important step in bringing THR-149 to patients and is designed to support our goal of positioning THR-149 as the treatment of choice for the large number of DME patients who have a sub-optimal response to anti-VEGF therapy. The KALAHARI study is progressing as planned, despite the widespread COVID-19 pandemic, and we anticipate announcing Part A dose selection data in mid-2021.

In 2020 we announced positive and highly promising Phase 1 results with THR-687. The data confirmed that this potential best in class pan-RGD integrin antagonist has the profile to become the standard of care for the majority of DME patients by replacing anti-VEGFs as the mainstay of DME therapy. We have carried out additional multiple dose preclinical studies to support the next phase of clinical development and remain on track to start a Phase 2 study in mid 2021. We are very excited by the potential for THR-687 given it has the possibility to be developed for other significant vascular retinal disorders including wet AMD and RVO.

We have also taken important steps to strengthen our management team. I am pleased to welcome Grace Chang, M.D. as our Chief Medical Officer, Tom Graney, C.F.A. as Chief Financial Officer, and more recently Professor Alan Stitt, Ph.D., as Chief Scientific Officer. We are delighted to be able to attract individuals with such great industry standing to Oxurion as we seek to advance our lead assets through the clinic towards commercialization and in parallel expand our pipeline of differentiated drug candidates. I am confident that we have a team that can deliver results, and 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

Oxurion remains focused on its strategy to deliver significant benefits to DME patients and other retinal vascular disorders globally as well as value to our shareholders. These goals are based on successfully advancing THR-149 and THR-687 which together have the potential to provide innovative tailored therapeutic solutions that deliver much improved clinical outcomes to all DME patients, and in the case of THR-687, also the broader market for retinal vascular disorders.

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Company; THR-149; THR-687; Investors