Bicycle Therapeutics and Oxurion Announce Full Enrollment in Phase I Trial for the Treatment of Diabetic Macular Edema

Oxurion Study of THR-149 Enrolls Early with 15 DME Patients

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle
Therapeutics, a biotechnology company pioneering a new class of
therapeutics based on its proprietary bicyclic peptide (Bicycle®)
product platform, and Oxurion today announced full enrollment of
Oxurion’s Phase I trial designed to evaluate the safety of a single
injection of THR-149, a novel Bicycle-based plasma kallikrein
(PKal) inhibitor. Activation of the PKal enzyme has been shown to induce
retinal vascular permeability, microaneurysm and inflammation.

“Patients with DME have elevated levels of PKal,” said Patrik De Haes,
M.D., Chief Executive Officer of Oxurion. “Our goal in this Phase I
trial is to evaluate the safety of a single intravitreal injection of
THR-149, a novel Bicycle-based PKal inhibitor, in subjects with
visual impairment due to DME. Enrolling these patients is the first step
to understanding whether we can inhibit PKal with Bicycle’s novel
bicyclic peptides.”

Under the terms of the agreement, Oxurion (formerly ThromboGenics) has
an exclusive license to undertake preclinical and clinical development,
as well as subsequent commercialization, of a specified drug candidate.
In return, Bicycle receives development milestone payments and royalties
on sales of products resulting from the collaboration.

“Bicycles offer a differentiated approach to a range of
debilitating diseases, and we are delighted to see the progress Oxurion
has made in successfully completing the enrollment of the first Bicycle-based
therapeutic for a Phase I study,” said Kevin Lee, Ph.D., Chief Executive
Officer of Bicycle Therapeutics. “THR-149, together with Bicycle’s own Bicycle
Toxin Conjugate for oncology, BT1718, represent the first of multiple
initiatives we are advancing to bring this unique therapeutic modality
to patients with substantial unmet medical needs.”

About Bicycle Therapeutics

Bicycle Therapeutics is a clinical-stage biopharmaceutical company
developing a novel class of medicines, referred to as Bicycles®,
for diseases that are underserved by existing therapeutics. Bicycles are
fully synthetic short peptides constrained to form two loops that
stabilize their structural geometry. This constraint is designed to
confer high affinity and selectivity, and the relatively large surface
area presented by the molecule allows targets to be drugged that have
historically been intractable to non-biological approaches. We have a
novel and proprietary phage display screening platform that we use to
identify Bicycles in an efficient manner. Our initial internal
programs are focused on oncology indications with high unmet medical
need. Our lead product candidate, BT1718, is a Bicycle Toxin
Conjugate being investigated for safety, tolerability and efficacy in an
ongoing Phase I/IIa clinical trial in collaboration with, and fully
funded by, the Centre for Drug Development of Cancer Research UK.
Bicycle was founded in 2009 as a result of innovative science conducted
by Sir Greg Winter and Professor Christian Heinis. Sir Greg Winter is a
pioneer in monoclonal antibodies; in 2018, he was awarded a Nobel Prize
in chemistry for the invention of the technology underpinning our
proprietary phage display screening platform that we use to identify Bicycles.
Bicycle is headquartered in Cambridge, U.K., with many key functions and
members of its leadership team located near the biotech hub of Boston,
Massachusetts. For more information, visit BicycleTherapeutics.com,
connect with us on LinkedIn and follow us on Twitter at @Bicycle_tx.

Contacts

Media:
Ten Bridge Communications
Sara Green
[email protected]
+1-617-233-1714

Investors:
Argot
Partners
Maeve Conneighton
[email protected]
+1-212-600-1902