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

Oxurion NV Business Update – Q3 2020

15 Oct 2020

Progressing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies – Beyond anti-VEGF

First Patient dosed in Phase 2 study (‘KALAHARI’) evaluating THR- 149, a potent plasma kallikrein inhibitor, for the treatment of DME

Tom Graney, CFA, former Vertex and Generation Bio CFO, appointed Chief Financial Officer

Grace Chang, M.D., Ph.D. appointed Chief Medical Officer

 

Highlights

  • First patient dosed in Phase 2 study (‘KALAHARI’) evaluating multiple injections of THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME in September
  • Tom Graney, CFA, former Vertex and Generation Bio CFO, appointed as Chief Financial Officer to Oxurion bringing significant operational, US capital markets and investor relations expertise
  • Grace Chang, M.D., Ph.D. appointed as Chief Medical Officer to lead the company’s clinical programs for THR-149 and THR-687 
  • Planning for a Phase 2 DME study with THR-687 a pan-RGD integrin antagonist ongoing, following positive Phase 1 data study released in January 

Financial

  • At the end of September 2020, Oxurion had cash, cash equivalents & investments of €31.6 million. This compares to €52.9 million at the end of December 2019.

Virtual R&D Day

Oxurion Virtual R&D Day –- today, Octobe152020 a5.30 PCET/4.3PM BST/11.30 AM ET,  featuring  Ramin  Tadayoni,  M.D.,  Ph.D.  and  Arshad Khanani, M.D., M.A. providing expert views on THR-149 and THR-687 clinical data and programs. For details of how to join the meeting: click here.

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Leuven, Belgium, Boston, MA, US - October 15, 2020 – 8.00 AM CET 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 complementary, 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-naïve 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 suboptimal 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 complementary 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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Tags: 
Company; THR-149; THR-687