Shares of Bicycle Therapeutics PLC BCYC, which debuted on Wall Street in May, traded higher on Monday morning.
What Happened
Bicycle Therapeutics, which derives its name from its proprietary bicyclic peptide technology that is used for developing therapeutics, said a Phase 1 study conducted by its partner Oxurion that evaluated the safety and tolerability of a single intravitreal injection of THR-149 in patients with diabetic macular edema, or DME showed no dose-limiting toxicities, or drug-related adverse events.
THR-149 is a Bicycle-based plasma kallikrein inhibitor.
The company also noted the activation of the inhibitor increased vascular permeability, microaneurysm and inflammation in DME. DME is an accumulation of fluid in macula, a part of the retina that controls most detailed vision abilities, due to leaking blood vessels and manifests as blurry or wavy vision near or in the center of the field of vision. It ultimately leads to permanent vision loss.
"These trial results represent additional human clinical data generated using Bicycles, a new therapeutic modality developed using our proprietary technology. It is impressive to see sustained activity out to 90 days in patients after a single injection, providing further support for the use of Bicycles in the ophthalmic setting," said Kevin Lee, CEO of Bicycle Therapeutics.
What Next
Bicycle's lead product candidate, BT1718, is a Bicycle Toxin Conjugate being investigated in an ongoing Phase 1/2a clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK.
The successful Phase 1 trial results of THR-149 takes the company beyond is oncology programs.
The company said it will build its strong collaboration with Oxurion, as the program moves into more advanced clinical development.
Bicycle shares traded higher by 9.4% to $11.01 in Monday's pre-market session.
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