Delivering next-generation treatments for back of the eye disorders, with focus on diabetic eye disease

Oxurion NV Business Update – H1 2019

5 Sep 2019

Positive Topline Phase 1 Results with THR-149 (Plasma Kallikrein Inhibitor) for treatment of DME 

Mixed Topline Results from exploratory THR-317 (anti-PlGF) Phase 2a ranibizumab combination study for the treatment of DME

THR-687 (Pan-RGD Integrin Inhibitor) Phase 1 study patient enrolment complete - Data read out by end of 2019

Total Cash & Investments at €67.6 million as of June 30, 2019 

Highlights

Pipeline

  • Positive topline data reported from Phase 1 safety study evaluating THR-149 (Plasma Kallikrein Inhibitor) for treatment of DME
    • THR-149 is well-tolerated and safe with no dose-limiting toxicities or drug-related serious adverse events reported.
    • Rapid onset of action starting at Day 1 with increasing average improvement in Best Corrected Visual Acuity (BCVA) at Day 14 following a single injection of THR-149.
    • Activity maintained at Day 90 following a single injection of THR-149.
    • Mixed topline data reported from exploratory Phase 2a combination study evaluating THR-317 in combination with ranibizumab for the treatment of DME
      • Combination therapy did not show increase in BCVA in the overall population at Month 3.
      • Certain improvement in mean BCVA at Month 3 observed with the combination therapy in poor (or non) responders to prior anti-VEGF, and with patients with poor vision - baseline BCVA ≤65 letters.
      • Topline data confirm THR-317 in combination with ranibizumab is safe and well-tolerated.
      • Patient enrolment completed in Phase 1 safety study evaluating THR-687 (pan RGD integrin antagonist) for treatment of DME
        • Company anticipates data read out by the end of 2019.

Financial

  • Oxurion reports €67.6 million in cash, cash equivalents & investments at the end of June 2019. This compares to €85.1 million at the end of December 2018.
  • Oxurion reports €1.8 million Jetrea® revenues for the period ending June 30, 2019. The Company decided to impair the remaining Jetrea® intangible assets.

Leuven, Belgium, September 5, 2019 – 17.40 CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease, today issues its business and financial update for the six-month period ending June 30, 2019.

Oxurion is continuing to progress the development of its innovative pipeline of disease modifying drug candidates for diabetic eye disease, particularly DME.

The Oxurion clinical development pipeline consists of novel products with different 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:

  • a potent plasma kallikrein inhibitor (THR-149) is in a Phase 1 multicenter, dose escalation study for the treatment of DME. Recent positive topline 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 very promising efficacy results in relation to BVCA.
  • a human placental growth factor (PlGF) neutralizing monoclonal antibody (THR-317).  

Topline results from an exploratory Phase 2a study evaluating the efficacy and safety of intravitreal THR-317 when administered in combination with ranibizumab (Lucentis®), for the treatment of DME. Oxurion is further analyzing all data and is evaluating its future plans for THR-317 in relation to the treatment of DME.

In addition, THR-317 is being evaluated in a Phase 2 study for the treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1), a rare disease that affects the macula and can lead to vision loss. First data from this study are expected towards the end of 2019.

  • a small molecule pan-RGD integrin antagonist (THR-687) being developed to treat a broad range of patients with diabetic eye disease. Phase 1 study with THR-687 completed patient enrolment in September 2019. Topline results from the Phase 1 study are expected by the end of 2019.

Patrik De Haes, M.D., CEO of Oxurion, said: “The positive topline results from a Phase 1 study confirm that THR-149, a potent plasma kallikrein inhibitor is well-tolerated and safe for intra-ocular use, and provides a rapid and sustained gain in BCVA. We believe that these positive findings demonstrate that THR-149 holds the potential to become a best-in-class PKal inhibitor for the treatment of DME. We are looking forward to the upcoming ‘late breaking’ podium presentation at the upcoming Euretina Congress in Paris and are currently in full preparation of a follow- up Phase 2 clinical trial evaluating THR-149 starting in early 2020.

“The recently reported topline results from an exploratory Phase 2 study evaluating THR-317 (anti-PlGF) in combination with ranibizumab for treatment of DME suggest that a combination therapy could play a certain role in the treatment of poor (or non) responders to prior anti-VEGF and with patients with a baseline BCVA of less or equal to 65 letters. We will continue to review and analyze these results, as well as last year’s reported positive Phase 1 results from the monotherapy study, before deciding on how to best position this program as we progress our overall clinical-stage portfolio of next-generation therapies for the treatment of DME. In making this decision, we will also take into account the outcome of the study evaluating THR-317 for treatment of MacTel1. The latter is expected for end of 2019.”

“Earlier this week we were happy to confirm that we have completed patient enrolment into our Phase 1 study evaluating the safety of our THR-687, a small molecule pan-RGD integrin antagonist for the treatment of DME. Topline data from this Phase 1 study will be reported before the end of 2019”, he continues.

“Our solid cash position of €67.6 million and prudent cash management will allow us to progress all of our ongoing and planned clinical and preclinical developments into 2021”, he concludes.

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