Leuven, Belgium. ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on developing novel medicines for diabetic eye disease, announced it will be highlighting its development plans in diabetic eye disease at the American Diabetes Association' 76th Scientific Sessions meeting on June 10 - 14, 2016 in New Orleans, Louisiana.
ThromboGenics is focused on developing novel medicines for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).
Over the last two years, ThromboGenics has developed an attractive pipeline of disease modifying drug candidates. The pipeline consists of THR-409, THR-317, both from its in-house research, as well as THR-149 which resulted from a research collaboration with Bicycle Therapeutics, and THR-687, which has been in-licensed from Galapagos NV.
These products all have different modes of action and allow the Company to address the four key segments of the evolving diabetic eye disease market:
- Non-proliferative DR with DME
- Non-proliferative DR without DME
- Proliferative DR with DME
- Proliferative DR without DME
ThromboGenics believes its diabetic eye disease pipeline is one of the strongest in the industry.
THR-409 for Non Proliferative Diabetic Retinopathy - Phase II Actively Recruiting Patients with NPDR
Early in 2016, the Company announced the initiation of the Phase IIa (CIRCLE) study. This study is evaluating the efficacy and safety of multiple doses of THR-409 (ocriplasmin) in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). The trial is being conducted at centers in the US, Canada and Europe.
ThromboGenics believes that by using multiple doses of THR-409 it can reduce the risk of patients' disease progressing from NPDR to proliferative diabetic retinopathy (PDR) by inducing a total PVD. Patients who progress to PDR are at high risk of experiencing severe vision loss or complete blindness. PDR is the major cause of blindness in patients with diabetes
Research has suggested that a total PVD, a complete separation of the vitreous and the retina, prevents the progression of NPDR to PDR. This could be explained by total PVD leading to elimination of the scaffold needed for the development of new blood vessels and/or the improvement of oxygen supply to the retina, thereby reducing retinal ischemia, production of VEGF, vascular outgrowth and neovascularization.
The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of up to 3 intravitreal injections of either 0.125mg or 0.0625mg (half of the approved dose) of THR-409 in subjects with moderately severe to very severe NPDR, to induce total PVD and reduce the risk of the patient progressing to sight-threatening PDR.
A total of 230 subjects will be recruited into the CIRCLE trial, approximately 92 in each THR-409 arm (0.125mg or 0.0625mg) and 46 in the sham arm.
The primary endpoint of the CIRCLE study is the percentage of patients with total PVD by the month 3 visit, confirmed by both B-scan ultrasound and SD-OCT.
The study has a number of secondary endpoints that are designed to provide further insights into ocriplasmin's potential in reducing the risk of progression of NPDR to PDR.
Further Disease Modifying Medicines in Development for Diabetic Eye Disease
In addition to THR-409, ThromboGenics is developing a number of other novel compounds that are targeting DR and DME. These are:
- THR-317 – a PLGF inhibitor being developed for DME and potentially as a combination therapy in conjunction with current anti-VEGF treatments. THR-317 is expected to enter the clinic by the end of 2016.
- THR-149 – a selective plasma kallikrein inhibitor being developed to treat DME associated with DR. This compound is the result of the Company's research collaboration with Bicycle Therapeutics.
- THR-687 – an integrin antagonist being developed to treat a broad range of patients with DR, with or without DME. THR-687 was in-licensed from Galapagos NV in March.
With this pipeline, ThromboGenics believes it can address the four key segments of the significant and growing diabetic eye disease market.
Dr Patrik De Haes, CEO of ThromboGenics nv, commented, "ThromboGenics is focused on progressing its drug development pipeline of potential new disease modifying medicines for the treatment of diabetic eye disease. We are currently recruiting patients into the CIRCLE study where we are looking to assess the ability of THR-409 to prevent patients with NPDR progressing to PDR, a disease state that could result in them losing their sight. Achieving this, by using up to 3 doses of THR-409 to generate a total PVD pharmacologically, would be a major advance in the overall treatment of diabetic retinopathy. With our other pipeline products, we are targeting both DR and DME, significant indications where there are clear unmet medical needs and a strong demand for improved or add-on treatment options."