Press release
Leuven, Belgium, 25 May 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 1 open-label, multicenter, dose escalation study evaluating the safety of THR-149 in the treatment of DME (NCT03511898).
THR-149 is a novel plasma kallikrein inhibitor generated using Bicycle Therapeutics' Bicycles® technology platform, and the kallikrein-kinin system is considered a valid target for the treatment of DME through inhibition of plasma kallikrein.
Preclinical studies have demonstrated the potency and efficacy of bicyclic peptide inhibitors of PKal, such as THR-149, supporting its progression into clinical trials for the potential treatment of DME, via a VEGF-independent mechanism.
The Phase 1 study (THR-149-001) will primarily assess the safety of a single intravitreal injection of escalating dose levels of THR-149 in patients with DME. Approximately 18 patients will be enrolled.
Initial results from the THR-149-001 study are anticipated in mid-2019.
Susan Schneider, MD, Chief Medical Officer of ThromboGenics , said: "We are pleased to have progressed THR-149 into clinical development by initiating this Phase 1 study. This is a key step in assessing THR-149's safety profile and its potential role in treating DME."
Patrik De Haes, MD, ThromboGenics CEO , commented: "Bringing THR-149 into the clinic marks the achievement of an important milestone in the progression of our pipeline, following the recent start of a Phase 2 with THR-317 in combination with Lucentis® in patients with DME. We also plan to bring THR-687, an integrin antagonist targeting diabetic retinopathy and DME, into the clinic mid-this year. We remain focused on developing all three of these disease-modifying candidates to allow us to generate value from the fast-growing diabetic eye disease market."
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For further information please contact:
| ThromboGenics Wouter Piepers, Global Head of Corp Coms & Investor relations +32 16 75 13 10 / +32 478 33 56 32 wouter.piepers@thrombogenics.com | Citigate Dewe Rogerson David Dible/ Sylvie Berrebi/ Isabelle Andrews Tel: +44 20 7638 9571 thrombogenics@citigatedewerogerson.com |
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' clinical pipeline consists of THR-317, a PlGF inhibitor, for the treatment of diabetic macular edema (DME), which is in an ongoing Phase 2 clinical study in combination Lucentis®, and THR-149, a plasma kallikrein inhibitor which is in a Phase 1 clinical study for DME. Another candidate, THR-687 (an integrin antagonist) is in late-stage preclinical development for the treatment of diabetic retinopathy and DME. THR-687 is expected to enter the clinic 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.
