The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
This trial was terminated before completion. Termination can indicate safety signals, futility findings, or business/regulatory decisions by the sponsor.
BioCryst Pharmaceuticals (BCRX) is the sponsoring company for this trial. BiotechSign currently grades this company C (55/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.