[Click e-Stock] "Curacle, Growing Expectations for Key Pipeline Performance"

On January 12, KB Securities analyzed that expectations are rising for clinical progress and potential technology transfer of Curacle's key pipelines.

Founded in 2016, Curacle is a small but strong biotech company developing a range of vascular disease treatment candidates based on its proprietary platform technology, SOLVADYS. The company holds eight candidates for the treatment of intractable vascular diseases, including the world’s first oral treatment for diabetic macular edema, CU06 (Rivasterat), and the oral treatment for diabetic nephropathy, CU01. Through open innovation, Curacle has also secured a 19.5% stake in Maptics, adding eight antibody drug candidates to its pipeline, bringing the total number of new drug candidates to sixteen.

Lim Kyunguk, a researcher at KB Securities, stated, “There is a need to pay attention to whether a global first-in-class drug can emerge from these sixteen diverse new drug candidates. Antibody therapeutics MT-101 and MT-103 have entered into material transfer agreements (MTAs) with several pharmaceutical companies and related research is underway, while discussions on additional agreements such as technology out-licensing are being actively pursued.”

The clinical progress of CU06, which is being developed as the world’s first oral treatment for retinal diseases, is also considered a major momentum driver. Lim emphasized, “Let’s focus on the clinical momentum of CU06, the world’s first oral treatment for retinal diseases under development. In the U.S. Phase 2a clinical trial results in 2024, positive data were announced, including improvements in visual acuity and safety in the treatment group of diabetic macular edema patients.” He added, “In December, a clinical contract was signed with a global CRO, and an IND application for Phase 2b is scheduled for the first half of 2026.”

The diabetic nephropathy treatment CU01 is also increasing its potential for technology out-licensing. Lim noted, “CU01, a diabetic nephropathy treatment with potential to improve uACR and eGHR, has completed domestic Phase 2b clinical trials. If favorable clinical results are announced, there is potential for technology out-licensing, although the opposite outcome is also possible.”

Curacle’s differentiating factor is the scalability of its proprietary vascular endothelial dysfunction inhibitor development platform, SOLVADYS. Lim analyzed, “Attention should be paid to the scalability of SOLVADYS, Curacle’s proprietary vascular endothelial dysfunction inhibitor development platform. Since the platform’s safety is confirmed at the early research stage, it is expected to enable faster clinical entry and higher clinical success rates compared to existing platforms.” He added, “Therefore, the strong point is its scalability, making it easier to expand indications to various diseases.”