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

Oxurion NV Business Update - Q1 2020

7 May 2020

Progressing Clinical Development of Next Generation Therapies for Diabetic Eye Disease – Beyond anti-VEGF

Total Cash & Investments at €43.8 million as of March 31, 2020

Highlights

  • Positive data from Phase 1 study evaluating THR-687 (Pan-RGD integrin antagonist) for the treatment of Diabetic Macular Edema (DME) announced in January 2020.
  • Preparations for planned Phase 2 study with THR-687 in DME on-going. Study expected to start in H1 2021.
  • Phase 2 study with THR-149 in DME is now expected to start H2 2020, or as soon as COVID-19 related safety considerations allow. Preparations progressing as planned.
  • At the end of March 2020, Oxurion had cash, cash equivalents & investments of €43.8 million.

Leuven, Belgium, May 7, 2020 – 17.45 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company engaged in the development of next-generation therapies to treat diabetic eye disease, today issues its business and financial update for the three months ending March 31, 2020.

Oxurion continues to progress the development of its pipeline of innovative drug candidates for treating Diabetic Macular Edema (DME). Diabetic eye disease, including DME, is a significant global healthcare problem and the major cause of blindness in adults of working-age.

Oxurion's clinical development pipeline consists of novel products with different, including non-VEGF, modes of action, which 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 Best Corrected Visual Acuity (BCVA) after a single injection and for up to 90 days of follow up.

THR-687: a small molecule pan-RGD integrin antagonist is being developed to treat a broad range of patients with diabetic eye disease. A Phase 1 study was completed in January 2020 and the data showed it to be well-tolerated and safe. The data also showed promising efficacy results with rapid onset of action and prolonged improvement in BCVA following a single injection.

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

"The positive Phase 1 results that we announced in January from the Phase 1 trial with THR-687 have strengthened Oxurion's position as a leader in developing safe and effective next generation therapies for DME and diabetic eye disease.

Based on the preclinical and clinical data to-date, THR-687, a small molecule pan-RGD integrin antagonist, clearly has the potential to deliver improved clinical benefits to a broader population of patients with diabetic eye disease than currently approved anti-VEGF treatments.

We are preparing a Phase 2 study with THR-687 which is expected to start in H1 2021.

We have delayed the start of our planned Phase 2 study evaluating multiple doses of THR-149 in patients with DME due to the current Covid-19 pandemic. We are continuing to prepare for this important trial and expect the study to start as soon as conditions allow us to proceed in an efficient manner, taking into account the safety of everyone who will be involved.

Our current cash position of €43.8 million will allow us to develop these exciting next generation therapies designed to provide both patients and physicians with improved treatment options for diabetic eye disease through mid-2021."

 Read the full press release here

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