Oxurion NV Business Update – Q3 2019
Positive Results from Phase 1 evaluating THR-149 for DME
Presented at major international Retina Conferences
Patient Enrolment Completed for THR-687 Phase 1 study
Data read out around year end 2019
Total Cash & Investments at €60.5 million as of September 30, 2019
Positive data from Phase 1 study evaluating THR-149 (Plasma Kallikrein Inhibitor) for the treatment of DME were presented at major Retinal Conferences
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) of up to 7.5 letters at Day 14 following a single injection of THR-149
Activity maintained up to 6.4 letters improvement at Day 90 following a single injection of THR-149
Patient enrolment completed in Phase 1 safety study evaluating THR-687 (pan RGD integrin antagonist) for the treatment of DME
Data read out anticipated around year end of 2019
Oxurion had cash, cash equivalents & investments of €60.5 million at the end of September 2019. This compares to €67.6 million at the end of June 2019.
Leuven, Belgium, October 18, 2019 – 7.30 AM 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 nine month period ending September 30, 2019.
Oxurion is continuing to progress the development of its innovative pipeline of drug candidates for diabetic eye disease, particularly Diabetic Macular Edema (DME).
The Oxurion clinical development pipeline consists of novel products with different mostly 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:
a potent plasma kallikrein inhibitor (THR-149) which completed a Phase 1 multicenter, dose escalation study for the treatment of DME. 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 very promising efficacy results in relation to BVCA.
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 around year end of 2019.
a human placental growth factor (PlGF) neutralizing monoclonal antibody (THR-317). Following 2018 reported positive topline data from a Phase 1 study evaluating THR-317 for DME in monotherapy, Oxurion recently reported mixed topline results from an exploratory Phase 2a study THR-317 in combination with ranibizumab (Lucentis®) for DME.
Oxurion is also evaluating THR-317 in a small Phase 2a study in Idiopathic Macular Telangiectasia Type 1 (MacTel 1). Topline data from this study are expected for early 2020. At that moment, Oxurion will announce its final overall development plans with THR-317.
Patrik De Haes, M.D., CEO of Oxurion, commented:
“The positive topline results from a Phase 1 study evaluating THR-149, a potent plasma kallikrein inhibitor, showed that THR-149 delivers a rapid and sustained gain in BCVA. The study also confirmed THR-149 was well-tolerated and safe.”
“We are pleased with the feedback from the ophthalmology community to these exciting new data, especially since they potentially create a path towards a new and unique VEGF-independent therapy for treatment of DME. We are preparing for a follow-up Phase 2 clinical trial that will evaluate multiple doses of THR-149. This important study is expected to start in the first half of 2020.”
“We are also looking forward to reporting the topline data from our Phase 1 study with THR-687, a small molecule pan-RGD integrin antagonist for the treatment of DME around year end. Our current cash of €60.5 million will allow us to progress all of our ongoing and planned clinical and preclinical developments into 2021.”
Diabetic Eye Disease - A Significant and Growing area of medical need
Diabetic eye disease is caused by hyperglycemia (high blood glucose levels) associated with diabetes. If left unchecked hyperglycemia causes damage to the capillaries supplying blood, and hence oxygen, to the retina, the structure at the back of the eye responsible for vison.
Diabetic retinopathy (DR) is a serious, sight-threatening disease and the leading cause of vision loss among working-age adults. DR progresses from mild, non-proliferative to more severe or even proliferative stages (PDR). PDR, the more advanced stage of diabetic eye disease happens when the retina starts growing new fragile blood vessels, which often bleed into the vitreous leading to loss of vision.
It is estimated that there are 150 million diabetics with DR of which 50 million have vision threatening disease.
Diabetic macular edema (DME) is a severe complication of DR. DME is an accumulation of fluid in the macula – the part of the retina that controls detailed vision - due to leaking blood vessels. DME represents an area of major unmet medical need. The current standard of care, anti-VEGFs, have shown to deliver sub-optimal results. More than 50% of patients have an unsatisfactory early visual response with anti-VEGF therapy, and in many cases, they fail to achieve a clinically meaningful visual improvement.