Oxurion NV Business Update - Q3 2018

 

Oxurion NV (Euronext Brussels: OXUR - formerly known as ThromboGenics), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diseases affecting the back of the eye, today issues a business update for the three-month period ending 30 September 2018.


Oxurion is developing a competitive pipeline of disease modifying drug candidates for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).

The Oxurion pipeline consists of products with different modes of action, and includes:

THR-317 - a PIGF (human placental growth factor) neutralizing monoclonal antibody, is in a Phase 2 study evaluating the efficacy and safety of intravitreal THR-317 when administered in combination with ranibizumab (Lucentis®), for 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). MacTel 1 is a rare disease that affects the macula and can lead to vision loss.

THR-149 - a plasma kallikrein inhibitor being developed for the treatment of DME. THR-149 is in a Phase 1 open-label, multicenter, dose escalation study

THR-687 - a small molecule integrin antagonist being developed to treat a broad range of patients with diabetic eye disease. THR-687 entered the clinic in September 2018.



Patrik De Haes, MD, CEO of Oxurion nv, commented: "This past quarter will be marked by the introduction of our new company name as we continue to make excellent progress in advancing our novel drug candidates in the clinic to treat diabetic eye disease. We began the clinical development of THR-687 as planned, and we started a new Phase 2 study evaluating THR-317 for the treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1). Earlier in the year we already announced the start of a Phase 2 study of THR-317 in combination with ranibizumab (Lucentis®) and a Phase I study with THR-149, both which are being developed for the treatment of DME. We look forward to the continued clinical advancement of our industry leading pipeline and expect to present initial clinical data in the second half of 2019.



Progressing Pipeline of Novel Medicines Targeting Diabetic Eye Disease

According to the International Diabetes Federation, the number of adults with diabetes worldwide is estimated at over 400 million and is expected to increase to over 640 million by 2040.
Diabetic eye disease is caused by hyperglycemia (high blood glucose levels) associated with diabetes. If left unchecked hyperglycemia causes damage to the capillaries in the back of the eye (retina) and can result in vision loss and subsequently, blindness.

Diabetic retinopathy (DR) is the leading cause of vision loss among working-age adults, affecting over a third of all people with diabetes. DR progresses from mild, non-proliferative to more severe or even proliferative stages.

Diabetic macular edema (DME) is an accumulation of fluid in the macula which can occur at any stage of diabetic retinopathy (DR). DME represents an area of unmet medical need; the current standard of care treatment with anti-VEGFs has been shown in some cases to result in suboptimal responses in patients.

THR-317-002 - a Phase 2 study evaluating an anti-PIGF antibody for treatment of DME

THR-317 (anti-PlGF) is a recombinant humanized monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF) being developed for the treatment of DME.

The first patient was recruited in a Phase 2 study evaluating the efficacy and safety of intravitreal THR-317 administered in combination with ranibizumab (Lucentis®), for the treatment of DME in April.

Initial results from this Phase 2 clinical study are anticipated for the second half of 2019.

Initiation of the Phase 2 trial followed Oxurion's announcement of Day 90 topline clinical data from the Phase 1/2 study evaluating THR-317 for DME. These data were reinforced by Day 150 topline clinical data that were announced in July.

At the Euretina International Congress in Vienna (Austria) in September, Oxurion gave a presentation on Anti-inflammatory effects of the PlGF neutralizing antibody THR-317 in patients with diabetic macular edema, providing further scientific findings supporting therapeutic potential of THR-317 as a promising new therapy for Diabetic Eye Disease.

THR-317-003 - a Phase 2 study evaluating an anti-PIGF antibody for treatment of MacTel1

In September, Oxurion announced the start of a Phase 2 open-label multi-center study evaluating the efficacy and safety of intravitreal THR-317 for the treatment of Macular Telangiectasia Type 1 (MacTel 1). MacTel 1 is a rare disease that affects the macula and can lead to vision loss. There is currently no cure or effective treatment for MacTel 1.

This Phase 2 study plans to enroll 10 patients with macular edema caused by MacTel 1, who will each receive three 8mg intravitreal THR-317 injections over a period of 2 months. Efficacy and safety of the therapy will be assessed via functional and anatomic endpoints.

Initial results from this clinical study are anticipated towards the end of the second half of 2019.


THR-149-001 - a Phase 1 study evaluating a plasma kallikrein inhibitor for treatment of DME

Plasma kallikrein for the treatment of DME acts through inhibition of the Plasma Kallikrein-Kinin (PKaI-kinin) System. Activation of the PKal-kinin system induces retinal vascular permeability, inflammation and angiogenesis. Based on literature data, patients with DME have elevated levels of plasma kallikrein, and therefore a plasma kallikrein inhibitor may be appropriate for the treatment of these patients.

In May, Oxurion initiated a Phase 1 clinical study evaluating the safety of a single intravitreal injection of escalating dose levels of THR-149 in patients with DME. Approximately 18 patients will be enrolled, with initial results anticipated around the end of the second half of 2019.

THR-687-001 - a Phase 1 study evaluating an integrin antagonist for the treatment of DME

Oxurion is developing THR-687, a novel pan-RGD integrin antagonist, to preserve vision of a broad range of patients with diabetic eye disease.

In September, THR-687 entered the clinic in a Phase 1 open-label, multicenter, dose escalation study evaluating the safety of a single intravitreal injection of THR-687 for the treatment of patients with diabetic macula edema (DME).

A maximum of 18 patients will be enrolled, with initial results anticipated by the end of the second half of 2019.

During the Euretina International Congress in Vienna (Austria) in September, preclinical data were presented supporting the therapeutic potential of THR-687 as a novel treatment for sight-threatening DR.

Oncurious Update - TB-403 for Pediatric Brain Cancers

Recruitment is on-going in a Phase 1/2a study with TB-403, a humanized monoclonal antibody against placental growth factor (PlGF), in the US. PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival.

The study aims to recruit 27 patients with Relapsed or Refractory Medulloblastoma. The purpose of this study is to evaluate the safety and tolerability of TB-403 at the maximum tolerated dose in pediatric subjects with relapsed or refractory Medulloblastoma.
Evaluation of the 3rd (out of 4) dose level is currently running towards its endpoint. For recruiting patients, Oncurious is partnering with Beat Childhood Cancer.

Initial data anticipated for around mid 2019.

TB-403 is being developed by Oncurious in conjunction with BioInvent International.

Financial Update

Oxurion had, at the end of September 2018, €95.1 million in cash and investments. This compares with €101.4 million as of the end of June 2018.

Note

Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing treatments to preserve vision in patients with diseases affecting the back of the eye. The company has built a diverse portfolio of disease-modifying therapies, including treatments for diabetic eye disease, a leading cause of blindness in people of working age worldwide.


Oxurion's clinical pipeline consists of THR-317, a PlGF inhibitor, for the treatment of diabetic macular edema (DME); THR-149, a plasma kallikrein inhibitor for the treatment of DME; and THR-687, a pan-RGD integrin antagonist for the treatment of diabetic retinopathy and DME. Further new drug candidates are currently being assessed and developed for the treatment of diabetic eye disease.


Oxurion owns the global rights to JETREA® (ocriplasmin), the only pharmacological vitreolysis drug approved for the treatment of symptomatic vitreomacular adhesion (in the U.S.) and vitreomacular traction (outside the U.S.).


Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. In the US, Oxurion NV operates ThromboGenics inc. as a subsidiary company. More information is available at www.oxurion.com

 

 

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