ThromboGenics Business Update – Q3 2016

20 Oct 2016

 

Diabetic Eye Disease clinical and pre-clinical programs on track

New Ophthalmic Research presented at EURETINA, EVER and AAO

Company Q3 2016 cash position at 88.2m Euro

 

Highlights

  • ThromboGenics continues to advance its attractive portfolio of novel medicines for the treatment of diabetic eye disease: 4 novel treatments for diabetic retinopathy (DR) - non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR), in the presence or absence of diabetic macular edema (DME)
  • ThromboGenics is conducting a Phase IIa clinical study (CIRCLE) evaluating THR-409 (ocriplasmin) to induce a complete posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
  • ThromboGenics is developing THR-317, an anti-PlGF inhibitor, for the treatment of DME. Program is on track to enter the clinic by end of 2016.
  • Preclinical work with THR-149, a plasma kallikrein inhibitor being developed to treat edema associated with diabetic retinopathy (DME), progressing as planned
  • ThromboGenics signed a global and exclusive license agreement with Galapagos to develop and commercialize integrin antagonists for the treatment of diabetic eye disease. The Company has started to explore the potential of these compounds, including THR-687, for the treatment of NPDR and PDR
  • ThromboGenics presented new preclinical and clinical data at several international ophthalmology expert meetings:
    • The European Society of Retina Specialists (EURETINA)
    • The European Association for Vision and Eye Research (EVER)
    • The American Academy of Ophthalmology (AAO)
  • Cash and investments were € 88.2 million as of the end of September 2016, compared with €91.5 million at end of June 2016 and €101.4 million at the end of December 2015


Leuven, Belgium, 20 october 2016.
ThromboGenics NV today issues a business and financial update for the nine months period ending 30 September 2016.

ThromboGenics is developing novel medicines for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).

Diabetes is a major global healthcare problem with 9% of adults (18 years and older) suffering from this disease(1).

Diabetic retinopathy (DR) is the leading cause of visual disability and blindness among professionally active adults(2). More than one in three living with diabetes (35.4%) will develop some form of DR in their lifetime. One in five patients with DR presents with DME.
DR progresses from mild, non-proliferative to more severe or even proliferative stages. As DR progresses, there is a gradual closure of retinal blood vessels leading to impaired perfusion and ischemia of the retina. When this progresses beyond certain thresholds, severe non-proliferative diabetic retinopathy (NPDR) is diagnosed.

The more advanced stage of DR, Proliferative DR (PDR), is characterized by the development of new blood vessels at the inner surface of the retina as a result of retinal ischemia. These new vessels are prone to bleed, resulting in vitreous hemorrhage. These new vessels may also undergo fibrosis and contraction, which may lead to epiretinal membrane formation, vitreoretinal traction bands, retinal tears and traction or retinal detachments.

PDR is considered high risk when the new vessels are accompanied by vitreous hemorrhage, or when they cover a significant area of the optic disc. Patients who progress to PDR are at high risk of severe vision loss.

ThromboGenics' strategy is focused on developing a strong pipeline of disease modifying drug candidates for diabetic eye diseases:

THR-409 - an ongoing Phase IIa (CIRCLE) clinical study is evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).

THR-317 - a PlGF neutralizing monoclonal antibody is being developed for DME and/or for use in combination therapy with current anti-VEGF treatments. THR-317 is expected to enter clinical development by end 2016.

THR-149 - a plasma kallikrein inhibitor is being developed to treat edema associated with diabetic retinopathy. (This compound has resulted from the Company's research collaboration with Bicycle Therapeutics)

THR-687 - a small molecule integrin antagonist being developed to treat a broad range of patients with diabetic retinopathy, with or without DME (in-licensed from Galapagos NV in 2016).

Dr. Patrik De Haes, ThromboGenics' CEO, said: "We are committed to achieving our goal of developing meaningful new treatments for patients suffering from diabetic eye diseases. With our current cash resources, we can support our activities for the foreseeable future, allowing us to demonstrate the value of our pipeline."

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1World Health Organization (WHO). (2015). Diabetes. Fact sheet N°312.
http://www.who.int/mediacentre/factsheets/fs312/en/ 21 May 2015.
2(Cunha-Vaz, 1998; Fong et al., 1999)