ThromboGenics Achieves Important Milestone in the Development of THR-149, A Novel Plasma Kallikrein Inhibitor for Diabetic Macular Edema

LEUVEN, Belgium, April 20, 2017 /PRNewswire/ --

ThromboGenics, a biotechnology company focusing on novel treatments for back of the eye disease and diabetic eye disease, announced it has achieved an important milestone in the advancing of the pre-clinical development of its THR-149, a novel plasma kallikrein inhibitor, which the company is developing for the treatment of Diabetic Macular Edema (DME). Following today's announcement, ThromboGenics will now start pivotal tox studies which are a last step before starting the clinical development which is expected for early 2018.

THR-149 is a bicyclic peptide (Bicycle®) identified as a lead candidate in the alliance between ThromboGenics and Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform.

Under the terms of the alliance agreement, ThromboGenics has an exclusive license to undertake pre-clinical and clinical development and subsequent commercialization of a specified drug candidate; in return Bicycle Therapeutics receives development milestone payments and royalties on sales of products resulting from the collaboration.

Bicycles are a novel class of small molecule medicines designed to overcome many of the limitations of existing drug modalities. They can be used as standalone therapeutic entities or coupled to deliver a variety of therapeutic payloads, and exhibit the affinity and exquisite target specificity usually associated with antibodies but in a small molecule format enabling rapid tissue penetration and flexible routes of administration.

"I am happy to report this important progress in our partnership with Bicycle Therapeutics," said Dr. Patrik De Haes, MD, Chief Executive Officer of ThromboGenics NV. "We believe that THR-149, a novel plasma kallikrein inhibitor, holds great promise for ophthalmology applications, expanding the range of treatment options available for people with diseases of the eye, particularly DME. We are rapidly moving towards the clinic, and expect to begin clinical development of THR-149 in early 2018."

"We're delighted to be realizing the first milestone from our Bicycle alliance with ThromboGenics and to see another Bicycle to be advancing towards the clinic for the treatment of a significant disease, in this case DME" said Dr. Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This achievement further validates Bicycle's technology and confirms the potential for Bicycles to be developed as a new therapeutic modality option to address a broad range of poorly treated diseases. We are continuing to expand our pipeline through strategic research collaborations which will extend our reach into new therapeutic areas and allow us to explore new applications for the Bicycle platform."

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 conducting the CIRCLE study, a Phase II clinical trial evaluating multiple doses of THR-409 (ocriplasmin) to induce a total Posterior Vitreous Detachment in patients with Non-Proliferative Diabetic Retinopathy (NPDR). Early 2017, ThromboGenics enrolled its first patient in a Phase II clinical study evaluating THR- 317, a PIGF inhibitor for the treatment of diabetic macular edema, as a stand-alone or as a combination therapy with anti-VEGF treatments. In addition, THR-149, a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics, and THR-687, an integrin antagonist, which was inlicensed from Galapagos, are in late stage pre-clinical development. ThromboGenics pioneered a new drug category of pharmacological vitreolysis with JETREA® (ocriplasmin) which is now approved for the treatment of vitreomacular traction in 54 countries worldwide. ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. in the US. Novartis commercializes JETREA® outside the United States. 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.

About Bicycle Therapeutics 

Bicycle Therapeutics is developing a new class of medicines to treat oncology and other important diseases based on its proprietary bicyclic peptide (Bicycle^®) product platform. Bicycles exhibit the affinity and exquisite target specificity usually associated with antibodies. Their small size enables rapid and deep tissue penetration, allowing tissues and tumours to be targeted from within. Their peptidic nature provides a "tuneable" pharmacokinetic half-life and a renal route of clearance, thus avoiding the liver and gastrointestinal tract toxicity often seen with other drug modalities. Bicycle Therapeutics is rapidly advancing towards the clinic with its lead programs using Bicycle Drug Conjugates^® to selectively deliver toxins to tumours. Bicycle Therapeutics is collaborating in oncology and other areas to realise the full potential of the technology. Bicycle Therapeutics' unique intellectual property is based on the work initiated at the MRC Laboratory of Molecular Biology in Cambridge, U.K., by the scientific founders of the company, Sir Gregory Winter and Professor Christian Heinis. Bicycle Therapeutics is headquartered in Cambridge, U.K., with a U.S. subsidiary in Cambridge, Massachusetts. For more information, visit www.bicycletherapeutics.com.

For contacting ThromboGenics nv

ThromboGenics
Wouter Piepers,
wouter.piepers@thrombogenics.com
+32-16-75-13-10 / +32-478-33-56-32

Citigate Dewe Rogerson
David Dible/Sylvie Berrebi
david.dible@citigatedr.co.uk
Sylvie.berrebi@citigatedr.co.uk
Tel: +44-20-7282-2867

For contacting Bicycle Therapeutics

Ten Bridge Communications (U.S.)
Sarah Sutton
Sarah@tenbridgecommunications.com
+1-857-242-1619

Consilium Strategic Communications (EU)
Mary-Jane Elliott/ Chris Gardner/ Ivar Milligan
Bicycle@consilium-comms.com
+44-20-3709-5700

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.