[Asia Economy Reporter Lee Gwan-joo] Curacle announced on the 27th that it has received the Clinical Study Report (CSR) for the Phase 1 clinical trial of 'CU06,' a treatment for diabetic macular edema and wet age-related macular degeneration, in the United States.
According to the report, the study was completed up to 1200 mg, which is 4 to 12 times the dosage used in the Phase 2 clinical trial, and no serious adverse reactions were observed at various dosages and administration methods, demonstrating its safety.
A Curacle representative stated, "Unlike developing drugs with widely known mechanisms of action, CU06 is a newly developed drug with a novel mechanism, so proving its safety was very important, and we have successfully completed this process. The synopsis for the Phase 2 clinical trial in the U.S. is already prepared, and after reviewing additional materials and converting data necessary for the clinical trial application, we plan to submit the Investigational New Drug (IND) application to the U.S. FDA.
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