Curacle applies for IND for 'CU06' diabetic macular edema Phase 2 clinical trial with US FDA
[Asia Economy Reporter Lee Gwan-ju] Curacle announced on the 24th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical trial of 'CU06' for diabetic macular edema.
Following the recently completed Phase 1 trial, which obtained safety data in healthy adults at various doses, the Phase 2a trial will involve oral administration of CU06 directly to patients with diabetic macular edema to secure data on therapeutic efficacy and safety.
Six to eight renowned hospitals in the United States are expected to participate in this clinical trial, with Dr. Charles Weikoff appointed as the principal investigator leading the study.
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Curacle stated, "We plan to complete the Phase 2a trial for diabetic macular edema as quickly as possible and proceed with a global Phase 2b trial involving multiple countries in the U.S. and Europe," adding, "We also plan to initiate a Phase 2a study for wet age-related macular degeneration."
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