5 July 2019 - - Belgium-based Oxurion (OTC: TBGNF) has released topline results from a Phase I clinical trial evaluating the safety and tolerability of a single intravitreal injection of THR-149, a novel Bicycle-based plasma kallikrein inhibitor, in patients with diabetic macular edema, UK-based biotechnology company Bicycle Therapeutics said.
No dose-limiting toxicities or drug-related adverse events were reported.
Activation of the PKal enzyme has been shown to increase retinal vascular permeability, microaneurysm and inflammation in DME.
This Phase I open-label, multi-center, non-randomized trial evaluated the safety of a single intravitreal injection of THR-149 at three ascending dose levels in 12 subjects with visual impairment due to center-involved DME.
The study also investigated changes to patients' best corrected visual acuity. A rapid onset of action was observed from Day 1, with an increasing average improvement in BCVA of up to 7.5 letters at Day 14.
This activity was maintained with an average improvement in BCVA of 6.5 letters at Day 90 following a single injection of THR-149.
In 2013, Bicycle entered into a research collaboration and license agreement with Oxurion (Euronext: OXUR) related to the discovery and development of novel human plasma kallikrein inhibitors for use in ophthalmic indications.
Bicycle Therapeutics (NASDAQ: BCYC) 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 with small molecule scaffolds to form two loops that stabilize their structural geometry.
This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development.
Bicycle's lead product candidate, BT1718, is a Bicycle Toxin Conjugate being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA.