ThromboGenics Reports Initial Data from its Clinical Study evaluating THR-317, an anti-PlGF, for the Treatment of Diabetic Macular Edema (DME)

Press release                                                     

Study results demonstrate safety and tolerability of THR-317 for intra-ocular use

30% of anti-VEGF treatment naïve patients had a 3 line or more (> or equal to 15 letters) gain in Best Corrected Visual Acuity (BVCA) after 3 monthly injections with THR-317 (8mg)

            Data from this clinical trial support initiation of a next study evaluating THR-317 in combination with an anti-VEGF 
             

Leuven, Belgium, April 4, 2018 - 7.30 AM CET - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for back of the eye diseases and focused on diabetic eye disease, reports topline results from a Phase 1/2, single-masked, multicentre study to evaluate the safety and efficacy of 2 dose levels (4 mg and 8 mg) of THR-317 for the treatment of diabetic macular edema (NCT03071068).

THR-317 (anti-PlGF) is a recombinant humanized monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF).  In pre-clinical models, anti-PlGF has been shown, in addition to anti-angiogenic and anti-edema properties, to also be anti-inflammatory. The THR-001 study enrolled a total of 49 patients, and included anti-VEGF naïve patients as well as sub-optimal anti-VEGF responders.

Initial data reported are for the anti-VEGF treatment naïve group (n=40) up to Day 90; 30 days after the last intravitreal (IVT) anti-PlGF administration. The primary focus of this study was safety outcomes. THR-317 was safe and well tolerated. No dose-limiting toxicities or relevant safety events were reported at either dose level.

30% of the anti-VEGF treatment naïve study subjects treated with THR-317 in the 8mg group showed a > or equal to 15 letter gain from baseline at Day 90 versus 5.3 % in the 4mg group.

These data support initiation of a next study evaluating THR-317 in combination with an anti- VEGF. Clinical trial is targeted to be initiated in Q2 2018.

Final results from the THR-317-001 study are being planned for presentation at an upcoming ophthalmology meeting.

Susan Schneider, MD, Chief Medical Officer of ThromboGenics nv comments: "This is a key step in our development of this novel compound for the treatment of patients with DME. We are very encouraged by these initial data that show safety and tolerability of THR-317 as well as clinical activity in this population. It is an exciting time for us at ThromboGenics as we continue to evaluate new therapeutics for diabetic eye disease. We believe that this remains an important area of unmet medical need."

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About THR-317 Phase 1/2 study

A Phase 1/2, single-masked, multicentre study to evaluate the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular edema (DME).  First clinical study evaluating safety and efficacy of an anti-PlGF antibody for intravitreal use.

The study evaluated the safety of 3 monthly IVT injections of 2 dose levels of THR-317 (4mg or 8mg).

The study enrolled 40 anti-VEGF treatment naive patients, and 9 anti-VEGF sub-optimal responders.

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on delivering innovative treatments for eye disease, with a focus on retinal disease. The company's pipeline of disease modifying drug candidates target diabetic eye disease.

ThromboGenics' is developing THR-317, a PlGF inhibitor, for the treatment of diabetic macular edema and plans to initiate a Phase 2 clinical study by Q2 2018.  ThromboGenics' late pre-clinical pipeline consists of THR-149, a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics, and THR-687, an integrin antagonist, which was in-licensed from Galapagos. THR-149 is targeted to enter the clinic in Q2 2018 and THR-687 around mid 2018. Further new drug candidates are currently being researched and developed.

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 (in Europe and elsewhere). 

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.