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

Oxurion NV Business Update – FY 2019

12 Mar 2020

Significant Progress with Innovative Pipeline candidates designed to deliver therapies for Diabetic Eye Disease – Beyond VEGF

Positive Results from Phase 1 study evaluating THR-149 (Plasma Kallikrein Inhibitor) for treatment of Diabetic Macular Edema (DME)  

Positive Results from Phase 1 study evaluatingTHR-687 (Integrin Antagonist) for treatment of Diabetic Macular Edema (DME)  

Global License Agreement for JETREA®signed with Inceptua Group 

Total Cash & Investments at €52.9 million as of December 31, 2019  

Highlights

Beyond VEGF Pipeline

  • Positive data from Phase 1 study evaluating THR-149 (plasma kallikrein inhibitor) for the treatment of DME announced in July 2019:
    • THR-149 is well-tolerated and safe. No dose-limiting toxicities or drug-related serious adverse events reported
    • Immediate onset of action (Day 1), high efficacy with increasing average improvement in BCVA following a single injection of THR-149
    • Retina expert data presentation delivered at Euretina 2019 and at Retina Society Meeting in London, UK
    • THR-149 is being developed as a potential treatment of choice for DME patients who respond sub-optimally to anti-VEGF therapy
    • Phase 2 study with anti-VEGF poor responding DME patients on track to be initiated by Q2 2020.
       
  • Positive data from Phase 1 study evaluating THR-687 (Pan-RGD integrin antagonist) for the treatment of DME announced in January 2020:
    • THR-687 is well-tolerated and safe. No dose-limiting toxicities or serious adverse events reported
    • Rapid onset of action, high efficacy and prolonged effect on Best Corrected Visual Acuity (BCVA) following a single injection 
    • Retina expert data presentation delivered at the Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2020 Meeting in Miami, US.
    • THR-687 is being developed as potential treatment of choice for all DME patients
    • Phase 2 study in treatment-naive patients expected to start in Q1 2021.
  • Decision to stop investment in all further development THR-317 anti-PIGF antibody program in order to focus resources on THR-149 and THR-687. 

Commercial

  • As part of the company’s strategy to achieve break-even for JETREA, Oxurion has entered into a global commercial license agreement for the distribution of JETREA with the INCEPTUA GROUP, a global pharmaceutical company and service partner. 

Financial

  • Oxurion had cash, cash equivalents & investments of €52.9 million at the end of December 2019. This compares to €60.5 million at the end of September 2019 and €85.1 million at the end of December 2018.

 

Leuven, Belgium, March 12, 2020 – 17.45 PM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care therapies, which are designed to better preserve vision in patients with diabetic eye disease, today issues its business and financial update for the twelve month period ending December 31, 2019. 

Oxurion has made significant progress with the development of its innovative pipeline of drug candidates for Diabetic Macular Edema (DME).

The Oxurion clinical development pipeline consists of novel products with different, including VEGF independent, modes of action, which together potentially give the Company access to a significant share of the large and fast-growing diabetic eye disease market.

Oxurion’s clinical pipeline comprises of  

  • THR-149: a potent plasma kallikrein inhibitor completed a Phase 1 multicenter, dose escalation study for the treatment of DME in July 2019.  Positive data showed that THR-149 is well-tolerated and safe with no dose-limiting toxicities or drug-related serious adverse events reported. The data also showed promising efficacy results in relation to BCVA after a single injection. 
  • THR-687: a small molecule pan-RGD integrin antagonist being developed to treat a broad range of patients with diabetic eye disease. Phase 1 study completed in January 2020 and the data showed it is well-tolerated and safe. The data also showed promising efficacy results with rapid onset of action and prolonged effect on BCVA following a single injection.

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

“The positive Phase 1 results that we have delivered in recent months from both our THR-149 and THR-687 programs have clearly positioned Oxurion as the leader in developing safe and effective next generation therapies for DME and diabetic eye disease more broadly, which go beyond VEGF.

These novel candidates have the potential of being a significant market opportunity, as it is known that 40% of DME patients respond poorly to any anti-VEGF therapy. We believe that those patients will have a better chance of achieving improved visual outcomes when treated with beyond-VEGF therapies such as THR-149 and THR-687.

Our THR-149 program, a potent plasma kallikrein inhibitor which acts via a completely VEGF independent pathway, has reported positive Phase 1 data showing that this compound is well placed to potentially become a treatment of choice for those DME patients who have previously responded sub-optimally to anti-VEGF therapy. 

Based on preclinical data and when compared to historical clinical data, THR-687, a small molecule pan-RGD integrin antagonist, has shown the potential to perform as well, if not better, than approved anti-VEGF treatments. This is particularly encouraging given our expectation that THR-687 could have a much broader therapeutic reach than anti-VEGFs.

We are preparing to begin a Phase 2 study with both compounds and expect to start our first trial evaluating multiple doses of THR-149 in Q2 2020. The Phase 2 study with THR-687 is expected to start in Q1 2021.

Our current cash of €52.9 million will allow us to initiate and progress Phase 2 development of these exciting novel compounds as we look to provide both patients and physicians with improved treatment options for the treatment of diabetic eye disease.”

Covid-19 Statement

“Oxurion is focused on ensuring the health and safety of its 80 employees and their families wherever they reside in the world.  We are continuing to monitor and adapt to this fast-moving situation. We have implemented restricted travel policies and are leveraging modern communication technologies as much as possible.  We also have implemented specific in-office sanitary guidelines and are allowing employees to work remotely when needed.

To-date, we have seen little or no impact on our daily operations, including our interactions with investigators, the investor community or other stakeholders.

As a result, we remain on track in all areas, particularly regarding our preclinical and clinical study planning, including our anticipated upcoming Phase 2 studies.”

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Company; THR-149; THR-687