[Asia Economy Reporter Hyungsoo Park] Curacle, a developer of treatments for intractable vascular diseases, is showing strong performance. The news that it 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, appears to have influenced its stock price.
As of 11:35 AM on the 27th, Curacle is trading at 19,900 KRW, up 18.1% from the previous trading day.
According to the report, CU06 completed studies up to 1200mg, which is 4 to 12 times the dosage planned for the upcoming Phase 2 clinical trial. No serious adverse reactions were observed at various dosages and administration methods, demonstrating excellent safety.
CU06 is a core asset developed through Curacle’s Solvadis platform, and last year, the company completed a technology transfer to Th?a, Europe’s leading ophthalmology specialist company, for indications including diabetic macular edema and wet age-related macular degeneration.
A Curacle representative stated, "Unlike developing drugs with widely known mechanisms of action, CU06 is a newly developed drug with a world-first mechanism, so proving its safety was very important."
He added, "Successfully completing this step brings us closer to developing a blockbuster drug. The synopsis for the Phase 2 clinical trial in the U.S. has already been prepared together with members of the top-level global Scientific Advisory Board (SAB)."
The representative also emphasized, "After completing the review of additional materials and data conversion necessary for the clinical trial application, we plan to submit the Investigational New Drug (IND) application to the U.S. FDA."
With the success of CU06’s Phase 1 trial, Curacle can now actively pursue the development of an innovative oral treatment with a new mechanism to replace existing intraocular injection therapies in the diabetic macular edema and wet age-related macular degeneration market, which is expected to reach 20 trillion KRW.
Additionally, the success of CU06’s Phase 1 trial has opened the path for Curacle to advance projects CU101 through CU106 directly to Phase 2 clinical trials without additional Phase 1 studies, accelerating development starting this year.
A Curacle representative introduced, "We plan to select pipelines with high success potential based on efficacy and marketability among the six projects CU101 to CU106, and enter global Phase 2 clinical trials, not only for diabetic macular edema and wet age-related macular degeneration but also for these projects."
He added, "Although many studies have been conducted recently, we have taken an important step toward providing patients with innovative treatments needed for various intractable vascular diseases related to vascular endothelial dysfunction, for which no treatments have yet been developed."
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