ThromboGenics Initiates Phase 2 Clinical Study Evaluating anti-PlGF (THR-317) in combination with anti-VEGF (ranibizumab) for treatment of Diabetic Macular Edema (DME)

Press release

Leuven, Belgium, April 27 2018 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for diabetic eye disease, announces that it has successfully enrolled the first patient in a Phase 2 active-controlled, masked, multicenter study to evaluate the efficacy and safety of THR-317 administered in combination with ranibizumab (Lucentis®, Novartis), for the treatment of DME (NCT03499223).

THR-317 (anti-PIGF) is a recombinant humanized monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF) administered by intravitreal (IVT) injection. In pre-clinical models, anti-PlGF has been shown, in addition to anti-angiogenic properties to also be anti-inflammatory.  

Ranibizumab is a monoclonal antibody fragment against vascular endothelial growth factor (VEGF), anti-VEGF being the current standard of care for the treatment of DME. Ranibizumab is administered intravitreally.  

This Phase 2 clinical study (THR-317-002) is designed to evaluate the safety and efficacy of IVT THR-317 along with ranibizumab, compared with ranibizumab monotherapy in patients with DME.

Patients will be randomized into either a combination arm of THR-317 (8mg) + ranibizumab, or ranibizumab plus a sham administration. The primary outcome measure is change from baseline in Best Corrected Visual Acuity (BCVA) at Month 3.

Simultaneous inhibition of VEGF (ranibizumab) and PlGF (THR-317) may have a better efficacy than either treatment alone. Non-clinical experiments indicate that anti-PlGF in the presence of an anti-VEGF antibody has an additive effect inhibiting the growth of new blood vessels (Van de Veire et al., 2010), a disease hallmark of DME. This may mean that a combination approach could result in a better treatment response.  The anti-PlGF component could bring the advantage of reduced inflammation associated with a reduced level of PIGF (van Bergen et al., 2017).  

Approximately 70 patients will be enrolled, of which about half will be anti-VEGF treatment naïve and the other half will have had a sub-optimal response to prior treatment with ranibizumab.

Initial results from the THR-317-002 study are anticipated in Q3 2019.

Susan Schneider, MD, Chief Medical Officer of ThromboGenics, said: "Initiating this clinical study is an important milestone in progressing the development of this novel compound for the potential treatment of patients with DME. A combination approach to treating this multifactorial disease may provide better therapeutic outcomes than current standard of care for the treatment of diabetic eye disease."

Patrik De Haes, MD, Chief Executive Officer of ThromboGenics, commented: "We are pleased to be moving THR-317 through clinical development as we continue to execute the strategic development of our novel diabetic eye disease pipeline. We look forward to bringing two additional candidates, THR-149 for the treatment of DME and THR-687 for the treatment of DR and/or DME, into the clinic this year."

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About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.

ThromboGenics' is developing THR-317, a PlGF inhibitor, for the treatment of diabetic macular edema, which is in an ongoing Phase 2 clinical study in combination with ranibizumab (Lucentis®, Novartis). ThromboGenics' late pre-clinical pipeline consists of THR-149, a plasma kallikrein inhibitor, and THR-687, an integrin antagonist. THR-149 is targeted to enter the clinic in H1 2018 and THR-687 around mid-2018. Further new drug candidates are currently being assessed and developed for the treatment of diabetic eye disease.

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

ThromboGenics is headquartered in Leuven, Belgium, and is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com

Important information about forward-looking statements

Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction.  No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.