Curacle announced on the 5th that it confirmed the vision improvement effect in the US Phase 2a clinical trial of its oral diabetic macular edema treatment ‘CU06’.
Curacle disclosed the top-line results of the Phase 2a clinical trial on the same day. This trial was conducted in the US with 67 patients with diabetic macular edema, administering CU06 orally once daily at doses of 100, 200, and 300 mg for 12 weeks. The primary endpoint was the change in central subfield thickness (CST) of the macula at 12 weeks compared to baseline to observe edema thickness, and the secondary endpoint measured the change in best corrected visual acuity (BCVA) score at 12 weeks compared to baseline to confirm vision improvement.
Diabetic macular edema is a complication of diabetes that occurs after diabetic retinopathy, characterized by edema in the macula, the central part of the retina. Since the macula is a critical area of the retina, edema can severely damage vision. Treatments such as 'Eylea' and 'Lucentis', which are also used for wet age-related macular degeneration, have been used as therapies.
The clinical results showed that CU06 did not increase the central subfield thickness value, the primary endpoint, in all dosage groups. In other words, it confirmed the effect of preventing the progression of edema. Improvement in the secondary endpoint, the maximum corrected visual acuity score, was also confirmed. In particular, among patients with low vision (maximum corrected visual acuity less than 0.5, 69 letters or fewer) even after correction with glasses or lenses, the 300 mg dose group improved the maximum corrected visual acuity score by an average of 5.8 letters.
Additionally, the therapeutic effect increased proportionally with the dose, and a pattern of sustained drug efficacy increasing over 1 to 3 months after administration was observed. No serious adverse events (SAEs) related to the drug occurred, demonstrating excellent tolerability.
A Curacle representative explained, “Real-world data (RWD) of vascular endothelial growth factor (VEGF) inhibitors, which have global sales of about 17 trillion KRW, show an average improvement of 5 to 5.4 letters in maximum corrected visual acuity at 12 months after administration. CU06 found a patient group that improved by 5.8 letters with only 3 months of administration, providing a clue to proceed with the Phase 2b clinical trial.”
Curacle plans to decide the design of the late-stage clinical trial through discussions with its partner Thea and the global clinical advisory board after the clinical study report (CSR) is released as early as the end of March, and aims to enter the Phase 2b clinical trial within this year.
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