Phase I results provide additional clinical activity data for Bicycles
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 (BCVA). 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.
“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. The safety and tolerability of THR-149 provides evidence of the clinical potential of this modality as we advance BT1718, our proprietary Bicycle Toxin Conjugate, which is currently in a Phase I/IIa clinical trial,” said
“With these favorable safety and tolerability results and initial data illustrating the long duration of action that can be obtained following a single injection of THR-149, we will continue our innovative, Bicycle-based approach to potential treatments for DME,” said
In 2013, Bicycle entered into a research collaboration and license agreement with
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